New CAR t therapy targets tough lymphoma

NCT ID NCT05370430

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing a new type of immune cell therapy called BAFFR-CAR T cells for people with relapsed or refractory B-cell Non-Hodgkin's lymphoma. The study aims to find a safe dose and check for side effects. About 36 adults whose cancer has not responded to prior treatments will take part.

What this could mean

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

Active substance
BAFFR-CAR T cells (a type of immune cell therapy)
What this could lead to
If it works, this could offer a new treatment option for patients with B-cell lymphoma who have not responded to other therapies.
What could go wrong
This is a very early Phase 1 trial with only 36 participants, so it is primarily testing safety and dosing. The therapy may not work, and there are risks like cytokine release syndrome and neurotoxicity.

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

About 36 people

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

Started

Jun 2022

Expected to finish

Jun 2028

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: 1. Informed Consent: Signed informed consent by the participant or legally authorized representative. 2. Age \& Performance Status: * Age ≥ 18 years * ECOG performance status ≤ 2 3. Diagnosis \& Disease Criteria: * Histologically confirmed B-NHL, including LBCL, MCL, and FL/MZL subtypes meeting specified prior treatment conditions. * BAFF-R expression on lymphoma cells required. 4. Measurable Disease: Tumor ≥1.5 cm on CT/PET scan or evidence of disease in blood, BM, GI, skin, or spleen. 5. Prior CAR T-cell Therapy: Allowed if ≥ 3 months since last treatment and CD19 CAR-T persistence \< 5% before leukapheresis. 6. Organ Function \& Laboratory Criteria: * Hematologic: ANC ≥ 1000/μL, Platelets ≥ 75,000/μL (exceptions for BM involvement). * Liver Function: Bilirubin ≤ 1.5x ULN (except Gilbert's), AST/ALT \< 3x ULN. * Renal Function: CrCl ≥ 50 mL/min. * Cardiac \& Pulmonary: LVEF ≥ 45%, QTcF ≤ 480 ms, O₂ saturation \> 91% on room air. 7. Infectious Disease Screening: Seronegative for HIV, active HBV, active HCV (or undetectable viral load if positive). 8. Reproductive Considerations: * Negative pregnancy test for females of childbearing potential. * Use of effective contraception or abstinence through 3 months post-treatment. Exclusion Criteria: 1. Prior Therapies \& Transplants: * Prior allogeneic SCT. * Autologous SCT \< 6 months before leukapheresis. * Concurrent systemic steroids or chronic immunosuppressant use. 2. Disease-Specific Exclusions: * Cardiac lymphoma involvement. * Need for urgent therapy due to tumor-related complications (e.g., bowel obstruction). 3. Medical Conditions: * Active autoimmune disease requiring immunosuppressants. * Primary immunodeficiency. * Cardiac conditions, including NYHA Class III/IV heart disease, arrhythmia, recent MI (≤ 6 months), stroke (≤ 6 months), or significant VTE (≤ 6 months). * Neurologic conditions, including prior optic neuritis, CNS inflammatory diseases, or seizure disorders. * History of malignancy, unless resected/treated with curative intent or in remission for ≥ 3 years. * Uncontrolled systemic infections or active CNS lymphoma. 4. Pregnancy \& Breastfeeding: Females who are pregnant or nursing. 5. Other Considerations: * Investigator-determined safety concerns. * Potential noncompliance with study procedures.

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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.

  1. The places running it

    6 sites. 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

  • Atrium Health Levine Cancer Institute - Morehead

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • City of Hope Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • Providence Swedish Cancer Institute

    RECRUITING

    Seattle, Washington, 98104, United States

  • Stanford University

    RECRUITING

    Stanford, California, 94305, United States

  • University of Kansas Hospital

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States