Can a smart chemotherapy outsmart resistant T-Cell cancers?
NCT ID NCT04315324
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This trial tests an experimental drug called OBI-3424 in people with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma that has returned or not responded to treatment. The drug is designed to become active mainly inside cancer cells that produce a specific enzyme, potentially killing the cancer while sparing healthy cells. Researchers are looking for the safest and most effective dose, and whether the drug can shrink or eliminate the cancer. Participants will receive the drug through an IV and undergo regular blood tests, bone marrow samples, and imaging to monitor their response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OBI-3424, a chemotherapy prodrug that becomes active inside cancer cells with high levels of a specific enzyme (AKR1C3)
- What this could lead to
- If it works, this could offer a new treatment option for people with T-cell leukemia or lymphoma that has stopped responding to standard therapies.
- What could go wrong
- This is an early-phase trial, so the drug may not work as hoped or may cause serious side effects. The results will need confirmation in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 67 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2021
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have a diagnosis of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) based on World Health Organization (WHO) classification. Patients with relapsed/refractory T-cell lymphoblastic lymphoma are eligible if lymphoblasts are \>= 5% in the bone marrow or in the peripheral blood by morphology or flow cytometry * Patients must have evidence of acute leukemia in their peripheral blood or bone marrow. Patients must have \>= 5% lymphoblasts in the peripheral blood or bone marrow within 14 days prior to registration. Patients with only extramedullary disease are not eligible * Patients ≥ 18 years of age must be refractory to or have relapsed following a standard induction chemotherapy. Patients \< 18 years of age must have relapsed or must be refractory after 2 or more chemotherapy cycles (example: induction and consolidation) * A standard chemotherapy induction regimen is defined as any program of treatment that includes: * Vincristine and corticosteroids plus at least one more chemotherapy agent * Cytarabine and anthracycline, or * High dose cytarabine (defined as at least 1 gr/m\^2 per individual dose unless adjustments were required for renal/liver function) * Patients must have no evidence of central nervous system disease within 28 days prior to registration based on cerebrospinal fluid (CSF) studies. Patients with clinical signs or symptoms consistent with central nervous system (CNS) involvement must have a lumbar puncture which is negative for CNS involvement; the lumbar puncture must be completed within 28 days prior to registration. Patients with CNS1 or CNS2 are eligible; however patients with CNS3 are not eligible * Note that the patients may receive intrathecal chemotherapy with the initial lumbar puncture. This may count as the first dose of intrathecal therapy required as part of the study * Prior nelarabine therapy is not required. In addition, for patients ≥ 18 years of age who received nelarabine during initial induction or post-remission treatment are eligible only if the physician does not feel they would benefit from other, multi-agent chemotherapy * Patients must not have had chemotherapy or investigational agents within 14 days prior to registration except for corticosteroids, oral 6-mercaptopurine, oral methotrexate, vincristine, intrathecal chemotherapy, or hydroxyurea. For participants who have received radiation therapy, at least 7 days must have elapsed from the end of radiation prior to registration and participants must not currently be experiencing toxicities from radiation therapy * Patients must not have undergone allogeneic hematopoietic transplant within 90 days prior to registration * Patients must have no evidence of active \>= grade 2 acute graft versus host disease (GVHD) or moderate or severe limited chronic GVHD. Patients must have no history of extensive GVHD of any severity within 90 days prior to registration. Patients who are post-transplant must be off calcineurin inhibitors for at least 21 days to be eligible. Extensive GVHD is defined as 1) generalized skin involvement or 2) localized skin involvement and/or hepatic dysfunction plus liver histology or cirrhosis or involvement of eye or minor salivary organ or oral mucosa or any other target organ * Patients must be \>= 12 years of age * Patients ≥ 16 years of age must have a Zubrod Performance Status of 0-3. Patients \< 16 years of age must have a Lansky score of ≥ 50 * Patients must not have systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) within 14 days prior to registration * Patients ≥ 18 years of age must have creatinine clearance \> 30 mL/min within 14 days prior to registration according to the Cockcroft Gault equation * Patients 12-17 years of age must have adequate renal function within 14 days prior to registration defined as serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN) according to age or a calculated estimated glomerular filtration rate (eGFR) (based on Schwartz formula) or radioisotope glomerular filtration rate (GFR) ≥ 50ml/min/1.73 m\^2 * Patients must have direct bilirubin =\< 1.5 x institutional upper limit of normal (ULN) within 14 days prior to registration * Patients must have alanine aminotransferase (ALT) =\< 3.0 x institutional upper limit of normal (ULN) or =\< 5.0 x ULN (if thought to be related to leukemic involvement) within 14 days prior to registration * Prothrombin time (PT)/partial thromboplastin time (PTT)/ fibrinogen (as clinically indicated for example but not limited to history of bleeding or active bleeding, concern for disseminated intravascular coagulation) (within 14 days prior to registration to obtain baseline measurements) * From metabolic panel (comprehensive or basic): sodium, potassium, chloride, carbon dioxide (CO2), and blood urea nitrogen (BUN) (within 14 days prior to registration to obtain baseline measurements) * Patients must be able to safely discontinue use of strong inhibitors/inducers of CYP3A4 or PgP-g-p and must be able to safely discontinue use of naproxen for 48 hours before and after each dose of OBI-3424 * Patients with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test within 6 months prior to registration. (HIV viral load testing is required only for patients with known HIV infection). Patients must not be receiving antiviral therapies that are known strong inhibitors or inducers of CYP3A4 * Patients with evidence of chronic hepatitis B virus (HBV) infection may be eligible provided that they have an undetectable HBV viral load within 28 days prior to registration. Patients may be currently receiving HBV treatment. (HBV viral load testing is required only for patients with known HBV infection). Patients must not be receiving antiviral therapies that are known strong inhibitors or inducers of CYP3A4 * Patients with known history of hepatitis C virus (HCV) infection may be eligible provided that they have an undetectable HCV viral load within in 28 days prior to registration. Patients may be currently receiving treatment. (HCV viral load testing is required only for patients with known HCV infection). Patients must not be receiving antiviral therapies that are known strong inhibitors or inducers of CYP3A4 * Patients must not have a known history of prolonged QT interval by Fridericia (QTcF) (interval \> 450 msec for males; \> 470 msec for females). Patients that had transient prolongation of QTc secondary to medications or electrolyte abnormalities are not excluded if the QTc normalized and remain within acceptable QTcF range (interval \> 450 msec for males; \> 470 msec for females). Additionally, suspected medications should be no longer required or used, and electrolyte abnormalities must have normalized * Patients must not be pregnant or nursing due to the teratogenic potential of the drug used on this study. Females of reproductive potential must have a negative serum pregnancy test within 14 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method during and up to 6 months after treatment. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures * Patients must not have other active malignancies for which they have received treatments within 6 months prior to registration excluding localized malignancies that do not require systemic treatment * Patients must agree to have bone marrow and blood specimens submitted for MRD testing * Patients must be offered the opportunity to participate in specimen banking. With patient consent, residuals from specimens submitted will be retained and banked for future research * Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with fedral, local, institutional and Central Institutional Review Board (CIRB) guidelines unless they are unable to provide consent based on age (\< 18 years) or based on impaired decision-making capabilities. For patients \< 18 years of age or with impaired decision making capabilities, parents or other legally authorized representatives must sign and give informed consent on behalf of study participants in accordance with applicable federal, local, institutional and CIRB regulations * As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system * This trial will use a slot reservation system to enroll the Phase I portion of the study. Patients planning to enroll at this phase of the study must first have a slot reserved in advance of the registration. All site staff will use OPEN to create a slot reservation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
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Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803, United States
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Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135, United States
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Ann M Wierman MD LTD
Las Vegas, Nevada, 89128, United States
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Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591, United States
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Augusta University Medical Center
Augusta, Georgia, 30912, United States
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Beacon Kalamazoo
Kalamazoo, Michigan, 49048, United States
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Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, 49009, United States
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Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
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Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
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Cambridge Medical Center
Cambridge, Minnesota, 55008, United States
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Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
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Cancer and Blood Specialists-Henderson
Henderson, Nevada, 89052, United States
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Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444, United States
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Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703, United States
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Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329, United States
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Children's Hospital Colorado
Aurora, Colorado, 80045, United States
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Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114, United States
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Children's Hospital of Orange County
Orange, California, 92868, United States
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
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Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507, United States
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Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108, United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
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City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
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Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
-
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
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Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169, United States
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Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052, United States
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Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
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Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144, United States
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Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, 89052, United States
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Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074, United States
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Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144, United States
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Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
-
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503, United States
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Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
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Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120, United States
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Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085, United States
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Corewell Health Reed City Hospital
Reed City, Michigan, 49677, United States
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Dell Children's Medical Center of Central Texas
Austin, Texas, 78723, United States
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Desert West Surgery
Las Vegas, Nevada, 89102, United States
-
Duke University Medical Center
Durham, North Carolina, 27710, United States
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El Paso Children's Hospital
El Paso, Texas, 79905, United States
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
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Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369, United States
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Fairview Lakes Medical Center
Wyoming, Minnesota, 55092, United States
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Fairview Northland Medical Center
Princeton, Minnesota, 55371, United States
-
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
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Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
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Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
-
GenesisCare USA - Fort Apache
Las Vegas, Nevada, 89148, United States
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GenesisCare USA - Henderson
Henderson, Nevada, 89074, United States
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GenesisCare USA - Las Vegas
Las Vegas, Nevada, 89109, United States
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GenesisCare USA - Vegas Tenaya
Las Vegas, Nevada, 89128, United States
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Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908, United States
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Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
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Health Partners Inc
Minneapolis, Minnesota, 55454, United States
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HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, 89149, United States
-
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, 89109, United States
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HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, 89113, United States
-
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, 89128, United States
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Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
-
Hope Cancer Care of Nevada
Las Vegas, Nevada, 89103, United States
-
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, 89048, United States
-
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
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Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
-
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
-
Kingman Regional Medical Center
Kingman, Arizona, 86401, United States
-
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805, United States
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Lakeview Hospital
Stillwater, Minnesota, 55082, United States
-
Las Vegas Cancer Center-Henderson
Henderson, Nevada, 89052, United States
-
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, 89148-2405, United States
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Las Vegas Prostate Cancer Center
Las Vegas, Nevada, 89113, United States
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Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, 89128, United States
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Las Vegas Urology - Green Valley
Henderson, Nevada, 89074, United States
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Las Vegas Urology - Pebble
Henderson, Nevada, 89074, United States
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Las Vegas Urology - Pecos
Las Vegas, Nevada, 89074, United States
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Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, 89128, United States
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Las Vegas Urology - Sunset
Las Vegas, Nevada, 89113, United States
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Loma Linda University Medical Center
Loma Linda, California, 92354, United States
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Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois, 60527, United States
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Loyola Medicine Homer Glen
Homer Glen, Illinois, 60491, United States
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Loyola University Medical Center
Maywood, Illinois, 60153, United States
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Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611, United States
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Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, 60160, United States
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Mary Greeley Medical Center
Ames, Iowa, 50010, United States
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McFarland Clinic - Ames
Ames, Iowa, 50010, United States
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McFarland Clinic - Boone
Boone, Iowa, 50036, United States
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McFarland Clinic - Jefferson
Jefferson, Iowa, 50129, United States
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McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158, United States
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McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501, United States
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Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
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Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
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Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229, United States
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Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337, United States
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Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
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Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
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Monticello Cancer Center
Monticello, Minnesota, 55362, United States
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Munson Medical Center
Traverse City, Michigan, 49684, United States
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New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
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North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
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North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
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Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Norton Children's Hospital
Louisville, Kentucky, 40202, United States
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OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102, United States
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OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148, United States
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OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128, United States
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OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052, United States
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Oregon Health and Science University
Portland, Oregon, 97239, United States
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Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808, United States
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Overlake Medical Center
Bellevue, Washington, 98004, United States
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PCR Oncology
Arroyo Grande, California, 93420, United States
-
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
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Prisma Health Richland Hospital
Columbia, South Carolina, 29203, United States
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Radiation Oncology Associates
Reno, Nevada, 89509, United States
-
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106, United States
-
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119, United States
-
Regions Hospital
Saint Paul, Minnesota, 55101, United States
-
Renown Regional Medical Center
Reno, Nevada, 89502, United States
-
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
-
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
-
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
-
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
-
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
-
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
-
Saint Mary's Regional Medical Center
Reno, Nevada, 89503, United States
-
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
-
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144, United States
-
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
-
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203, United States
-
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503, United States
-
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444, United States
-
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451, United States
-
United Hospital
Saint Paul, Minnesota, 55102, United States
-
Unity Hospital
Fridley, Minnesota, 55432, United States
-
University Cancer Center
Las Vegas, Nevada, 89169, United States
-
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
-
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
-
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
-
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462, United States
-
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
-
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
-
University of Illinois
Chicago, Illinois, 60612, United States
-
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
-
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
-
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
-
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
-
University of Rochester
Rochester, New York, 14642, United States
-
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
-
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
-
University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
-
Urology Specialists of Nevada - Central
Las Vegas, Nevada, 89106, United States
-
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074, United States
-
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
-
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, 89113, United States
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VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
-
Valley Medical Center
Renton, Washington, 98055, United States
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Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
-
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
-
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
-
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
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