Experimental cell therapy takes on tough blood cancers
NCT ID NCT04629729
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new treatment called FT819 for people with B-cell cancers (lymphoma, CLL, or B-ALL) that have not responded to standard therapies. The goal is to find a safe dose and see if the therapy can shrink tumors. About 54 participants will receive FT819 alone or with another drug (IL-2) to boost its 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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
54 people
The number who actually took part.
- Started
-
Jul 2021
- Expected to finish
-
Sep 2039
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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.
Key Inclusion Criteria: Diagnosis of B-cell lymphoma, CLL or B-ALL as described below: B-Cell Lymphoma: * Histologically documented lymphomas expected to express CD19 * Relapsed/refractory disease following at least 2 prior lines of multi-agent immunochemotherapy Chronic Lymphocytic Leukemia (CLL): * Diagnosis of CLL per iwCLL guidelines * Relapsed/refractory disease following at least two prior systemic treatment regimens Precursor B-cell Acute Lymphocytic Leukemia (B-ALL): * Diagnosis of B-ALL by flow cytometry, bone marrow histology, and/or cytogenetics * Relapsed/refractory disease after at least 2 cycles of standard multiagent induction chemotherapy. For subjects with Philadelphia-chromosome positive (Ph+) disease, failure or intolerance to a tyrosine kinase inhibitor therapy-containing regimen ALL SUBJECTS: * Capable of giving signed informed consent * Age ≥ 18 years old * Stated willingness to comply with study procedures and duration * Contraceptive use for women and men as defined in the protocol Key Exclusion Criteria: ALL SUBJECTS: * Females who are pregnant or breastfeeding * Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2 * Body weight \<50 kg * Evidence of insufficient organ function * Receipt of therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Day 1 * Currently receiving or likely to require systemic immunosuppressive therapy * Ongoing requirement for systemic GvHD therapy following prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T * Receipt of an allograft organ transplant * Known active central nervous system (CNS) involvement by malignancy * Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease * Clinically significant cardiovascular disease * Positive serologic test results for HIV infection * Positive serologic and polymerase chain reaction (PCR) test results for Hepatitis B (HBV) infection * Positive serologic and PCR test results for Hepatitis C (HCV) infection * Live vaccine \<6 weeks prior to start of lympho-conditioning * Known allergy to albumin (human) or DMSO
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic lymphocytic leukemia are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
-
MD Anderson Cancer Center
Houston, Texas, 77030, United States
-
Mayo Arizona
Phoenix, Arizona, 85054, United States
-
Mayo Florida
Jacksonville, Florida, 32224, United States
-
Mayo Minnesota
Rochester, Minnesota, 55905, United States
-
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
-
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, 40207, United States
-
Oregon Health & Sciences University
Portland, Oregon, 97239, United States
-
Scripps Green Hospital
La Jolla, California, 92037, United States
-
Stanford Cancer Institute
Palo Alto, California, 94304, United States
-
The University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
-
UC Davis
Davis, California, 95817, United States
-
UCLA Ronald Reagan Medical Center
Los Angeles, California, 90095, United States
-
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
-
University of Florida
Gainesville, Florida, 32608, United States
-
University of Iowa
Iowa City, Iowa, 52242, United States
-
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
-
University of Wisconsin-Madison
Madison, Wisconsin, 53705, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can AI spot the lymphoma patients who Won't respond?
- Two-Drug combo aims to push CLL into deep remission
- Can a new BTK inhibitor outsmart resistance in CLL?
- Can a new pill outsmart Drug-Resistant leukemia?
- Can engineered immune cells beat tough B-Cell cancers?
- Can a targeted drug outperform chemo for a common blood cancer?