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Off-the-Shelf CAR t therapy shows promise for Hard-to-Treat lymphoma

NCT ID NCT04416984

Disease control Sponsor: Allogene Therapeutics Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new type of CAR T cell therapy, called ALLO-501A, made from donor cells (not the patient's own). It is for adults with large B-cell lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma that has come back or not responded to other treatments. The goal is to see if this therapy is safe and can shrink or control the cancer after a short course of chemotherapy. About 160 people will take part.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2020

Expected to finish

May 2029

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.

Inclusion Criteria: For subjects with LBCL: * Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse per WHO 2017 * At least 1 measurable lesion at time of enrollment * Relapsed or refractory disease after at least 2 lines of chemotherapy * Absence of significant donor (product)-specific anti-HLA antibodies (DSA) at screening (Note: Only applicable for Phase 2) For subjects with CLL/SLL: * Diagnosis of CLL/SLL * Relapsed/refractory disease * Subjects relapsed/refractory to BTKi therapy and high-risk disease * Subjects relapsed/refractory with 2 or more lines of therapy including BTKi and BCL-2 inhibitor (venetoclax) * At least 1 measurable lesion at time of enrollment For all subjects: * Male or female subjects ≥18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 * Adequate hematological, renal, and liver function Exclusion Criteria: * Active central nervous system (CNS) involvement by malignancy * Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy * Any other active malignancies that required systemic treatment within 3 years prior to enrollment * Radiation therapy within 2 weeks prior to ALLO-647 * Prior irradiation to \>25% of the bone marrow * Hypocellular bone marrow for age by institutional standard as determined from a bone marrow biopsy performed at time of screening (Note: Only applicable for Phase 2). * Autologous hematopoietic stem cell transplant (HSCT) within last 6 months (24 weeks) * Systemic anti-cancer therapy within 2 weeks prior to receiving ALLO-647

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia chronic lymphocytic leukemia/small lymphocytic lymphoma leukemia lymphoma Recurrence relapsed/refractory diffuse large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed or refractory large B cell lymphoma, relapsed or refractory chronic lymphocytic leukemia, relapsed or refractory small lymphocytic lymphoma

Contacts and locations

Locations

  • Advent Health

    Orlando, Florida, 06510, United States

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Avera Medical

    Sioux Falls, South Dakota, 57117, United States

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • CHU de Québec -Université Laval; Hôpital de l'Enfant-Jésus

    Québec, Quebec, G1J 1Z4, Canada

  • City of Hope

    Duarte, California, 91010, United States

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218-1234, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • MD Anderson Cancer Center - University of Texas

    Houston, Texas, 77030, United States

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612-9416, United States

  • Monash Medical Centre

    Clayton, Victoria, 3168, Australia

  • Northside Hospital - Atlanta

    Atlanta, Georgia, 30342, United States

  • Norton Cancer Institute

    Louisville, Kentucky, 40207, United States

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • QEII Health Sciences Centre-VG Site

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • St. David's South Austin Medical Center

    Austin, Texas, 78704, United States

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065, Australia

  • Stanford Cancer Institute

    Palo Alto, California, 94035, United States

  • Texas Oncology

    Dallas, Texas, 75251, United States

  • UCLA Medical Center

    Los Angeles, California, 90095, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Yale School of Medicine

    New Haven, Connecticut, 06510, United States

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