Engineered immune cells take aim at stubborn leukemia
NCT ID NCT06871410
First seen Jun 25, 2026 · Last updated Aug 18, 2026 · Updated 7 times
Summary
This early-phase trial is testing a new cell therapy called CD83 CAR T cells in 26 adults with acute myeloid leukemia (AML) that has returned or not responded to treatment. The therapy uses a patient's own immune cells, genetically modified to recognize and attack a protein (CD83) found on leukemia cells. The main goal is to find a safe dose and check for side effects, while also seeing if the treatment can shrink the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CD83 CAR T cells (a genetically engineered immune cell therapy)
- What this could lead to
- If it works, this could offer a new treatment option for patients with hard-to-treat AML, potentially reducing the risk of relapse after stem-cell transplant.
- What could go wrong
- This is a very early phase I trial with only 26 participants, so safety and dosing are still being figured out. The therapy may not work, and there are risks like cytokine release syndrome or other side effects.
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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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18 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: * Age ≥ 18 years old. * Karnofsky performance status score ≥ 70%. * Relapsed or refractory AML based upon ELN 2022 criteria. * Creatinine clearance: ≥ 40 mL/min (Cockroft-Gault). * Total bilirubin: ≤ 2mg/dL except for patients with Gilbert's syndrome, hemolysis, or related to disease. * Aspartate aminotransferase (AST) and alanine transaminase (ALT) \< 3.0 x upper limit of normal (ULN). * Left ventricular (LV) ejection fraction: \> 45% and be free of symptomatic congestive heart failure or uncontrolled arrhythmia. * Oxygen (O2) saturation: ≥ 92% on room air without needs for supplemental O2. * Absolute lymphocyte count: ≥ 0.2 x 10\^9/L, HCT of ≥ 27% and platelets of ≥ 20 x 10\^9/L. Transfusion support is allowed to meet HCT and platelet parameters prior to apheresis. * Life expectancy ≥12 weeks from the time of enrollment, per clinical judgment. * Negative serum pregnancy test in females of child-bearing potential (FOCBP). FOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. * If history of allogeneic HCT, must have completed transplant at least 3 months prior, be off immunosuppression, including ruxolitinib, at least 2 weeks prior to apheresis, and have no evidence of GVHD requiring treatment at enrollment. * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 12 months following duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Participants must be considered preliminarily eligible for an allogeneic hematopoietic cell transplantation, with potential donors identified per a transplant and cellular therapy consult at Roswell Park Comprehensive Cancer Center. * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure. Exclusion Criteria: * Concomitant systemic glucocorticoid use at a dose equivalent to \> 10 mg daily prednisone at the time of apheresis and/or within 4 weeks of CD83 CAR T infusion for any reasons other than GVHD. * Diagnosis of acute promyelocytic leukemia (APL; AML M3 by French-American-British \[FAB\] classification). * Active central nervous system (CNS) leukemia; patients with history of CNS leukemia in complete response (CR) are eligible. * Patients enrolled in another investigational therapy protocol for their disease within 14 days or 5 half-lives prior to leukapheresis, whichever is shorter. * Patients requiring agents or any treatments other than hydroxyurea, single agent cytarbine,hypomethylating agents with or without ventoclax and/or targeted agents (i.e., FLT3, IDH2 or IDH1 inhibitors) to control blast counts within 14 days or 5 half-lives (whichever is shorter) prior to lymphodepletion. * Ongoing uncontrolled serious infection, pulmonary disease or psycho/social concerns. * HIV seropositivity or active hepatitis B or C infection within (defined by positive polymerase chain reaction \[PCR\]) 4 weeks of enrollment. * Other active malignancy within 2 years of study entry, except for basal cell cancer of skin, cervical cancer treated surgically with curative intent or localized prostate cancer managed with observational approach. * Active grade II-IV acute GVHD in patients with relapsed AML after HCT requiring treatment. * Prior solid organ transplant. * Active autoimmune disease requiring immunosuppressive therapy. * Pregnant or nursing female participants. * Unwilling or unable to follow protocol requirements. * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Roswell Park Cancer Institute
RECRUITINGBuffalo, New York, 14263, United States
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Other studies related to the condition(s) this trial covers.
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- Gentler chemo approach shows promise for tough blood cancers in older patients
- Selective immune cell removal may tame transplant complications
- Promising combo for IDH1 leukemia hits early snag – trial stopped