New CAR t therapy targets tough lymphoma
NCT ID NCT05370430
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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.
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.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Atrium Health Levine Cancer Institute - Morehead
RECRUITINGCharlotte, North Carolina, 28204, United States
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City of Hope Medical Center
RECRUITINGDuarte, California, 91010, United States
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Providence Swedish Cancer Institute
RECRUITINGSeattle, Washington, 98104, United States
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Stanford University
RECRUITINGStanford, California, 94305, United States
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University of Kansas Hospital
RECRUITINGKansas City, Kansas, 66160, United States
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University of Minnesota
RECRUITINGMinneapolis, Minnesota, 55455, United States