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Experimental cell therapy takes on tough blood cancers

NCT ID NCT04629729

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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

  • 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

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