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Off-the-Shelf CAR-T cells take on tough blood cancers

NCT ID NCT07284433

Disease control Sponsor: AvenCell Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 1 time

Summary

This study tests a new CAR-T therapy made from donor cells, so it's ready to use without waiting for a patient's own cells to be modified. It targets two proteins on cancer cells to lower the chance of the cancer coming back. About 178 adults with relapsed or refractory B-cell lymphoma or leukemia will receive one infusion after chemotherapy. The main goals are to find a safe dose and see how many patients achieve complete remission by week 13.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Allo-QuadCAR01-T (donor CAR-T cells targeting CD19 and CD20)
What this could lead to
If it works, this could provide a faster, cheaper off-the-shelf treatment option for patients with relapsed or refractory B-cell cancers.
What could go wrong
This is an early Phase 1/2 trial, so safety and effectiveness are not yet proven. There are risks of severe side effects like cytokine release syndrome or graft-versus-host disease.

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 178 people

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

Started

Jan 2026

Expected to finish

Nov 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: * Adults 18 years or older. * Diagnosed with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) or chronic lymphocytic leukemia (CLL). * Must have received at least 2 prior lines of therapy. * ECOG performance status 0-1 (able to carry out daily activities). * Adequate organ function (heart, liver, kidneys). * HLA B/C match with donor cells. * No active uncontrolled infections. Exclusion Criteria: * Active CNS involvement (including PCNSL) in dose escalation cohorts; may be allowed in later cohorts with Sponsor approval. * Prior CAR-T within 3 months of screening, or ≥Grade 3 ICAHT from prior CAR-T. * Autologous stem cell transplant within 3 months. * Prior allogeneic stem cell transplant or solid organ transplant. * Prior therapy with dual CD19/CD20 CAR-T. * Severe hypersensitivity to trial agents or similar compounds. * History of GvHD or post-transplant lymphoproliferative disorder. * Presence of La/SS-B autoantibodies or related autoimmune diseases. * Other malignancy that may interfere with trial, except: * Curatively treated basal/squamous skin cancer or cervical carcinoma in situ * Low-grade, early-stage prostate cancer (Gleason ≤6, Stage 1-2) with no therapy needed * Adjuvant endocrine therapy for non-metastatic breast cancer (≥2 years) * Any other curatively treated malignancy in remission ≥2 years * Active viral infection within 1 week of screening, or serious bacterial/fungal infection. * Hemorrhagic cystitis. * Active neuro-autoimmune disease (e.g., MS, Guillain-Barré, ALS). * Active or residual HBV, HCV, or syphilis. * Active HIV. History of HIV may be eligible with Sponsor approval if: * Neurological disorders within 6 months (e.g., stroke, dementia, Parkinson's, cerebellar disease, CNS autoimmune disease). * Significant cardiac disease within 6 months (e.g., MI, stent, unstable angina). * Primary immunodeficiency or autoimmune disease requiring systemic treatment within 1 year (unless stable and Sponsor-approved). * Unresolved ≥Grade 2 non-hematologic toxicity from prior therapy (except neuropathy up to Grade 2). * Systemic immunosuppression within 28 days. * Last systemic lymphoma/CLL therapy (standard or investigational) within 28 days or 5 half-lives. * Major surgery within 14 days. * Local radiation within 28 days. * Live vaccination within 28 days. * Pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia B-cell non-Hodgkin lymphoma diffuse large B-cell lymphoma hematopoietic and lymphoid cell neoplasm leukemia lymphoma

As listed by the trial registrant

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

Leukemia and lymphoma Leukemia relapse Lymphoma receiving car-T therapy Lymphoma, diffuse large B-cell

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Brown University Health

    NOT_YET_RECRUITING

    Providence, Rhode Island, 02903, United States

  • Charité Universitätsmedizin Berlin

    RECRUITING

    Berlin, 13353, Germany

  • Klinikum der Universität München

    RECRUITING

    Munich, Bavaria, 81377, Germany

  • MD Anderson Cancer Center

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Northwestern University

    NOT_YET_RECRUITING

    Evanston, Illinois, 60208, United States

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Uniklinikum Erlangen

    NOT_YET_RECRUITING

    Essen, North Rhine-Westphalia, 45147, Germany

  • University of Chicago

    NOT_YET_RECRUITING

    Chicago, Illinois, 60637, United States

  • Universitätsklinikum Dresden

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • Universitätsklinikum Erlangen

    RECRUITING

    Erlangen, Bavaria, 91054, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    NOT_YET_RECRUITING

    Hamburg, 20246, Germany

  • Universitätsklinikum Marburg

    NOT_YET_RECRUITING

    Marburg, Hesse, 35032, Germany

  • Universitätsklinikum Ulm

    RECRUITING

    Ulm, Baden-Wurttemberg, 89081, Germany

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