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BAFFR-CAR T Cells for Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

This study is testing a new treatment called BAFFR-CAR T cells for people with B-cell Non-Hodgkin's Lymphoma (B-NHL) that has come back or isn't responding to other treatments. BAFFR-CAR T cells are made from your own infection-fighting T cells, which are specially modified to recognize and kill cancer cells that have a protein called BAFFR on their surface. This is a first-in-human study to see how safe BAFFR-CAR T cells are and if they can help treat B-NHL. We are looking for 36 participants aged 18 or older who meet specific health and diagnosis criteria. The main goals are to understand any side effects and find the best dose of the treatment.

Study design
This is a Phase 1 interventional study, meaning it's an early-stage trial to test safety and dosage. It plans to enroll 36 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to one year after treatment, with a specific safety evaluation period of 28 days after the infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05370430

BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL

Recruiting
PHASE1Ages 18+InterventionalTreatment
PeproMene Bio, Inc.
~36 participants
Updated 2025-11-20 on ClinicalTrials.gov
What's tested:BAFFR-CAR T cells

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 1 year post treatment
+1 more outcome measured

Conditions

Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

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B-Cell Non-Hodgkin LymphomaFollicular LymphomaMantle Cell LymphomaMarginal Zone LymphomaTumor Necrosis Factor Receptor Superfamily Member 13C

Where it's being run

6 sites across 5 states
California2
Kansas1
Minnesota1
North Carolina1
Washington1

Study leadership

  • Elizabeth Budde, MD · STUDY_CHAIR · City of Hope Medical Center

Who to contact

Hazel (Ting-Ying) Cheng, PhD
[email protected]
714-599-8077
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Incidence of adverse eventsUp to 1 year post treatment

    Assess the safety of administering BAFFR-CAR T cells in participants with relapsed or refractory (r/r) B-cell Non-Hodgkin's Lymphoma (B-NHL) and it's subtypes. Toxicity will be graded per Common Terminology Criteria for Adverse Events version 5.0, Cytokine Release Syndrome (CRS) and neurotoxicity which use the American Society for Transplantation and Cellular Therapy Consensus Criteria (ASTCT) and Graft versus Host Disease (GVHD) criteria. Toxicities will be followed from the start of lymphodepletion until the end of the study.

  • Maximum Tolerated Dose (MTD)The DLT evaluation period is defined as 28 days following BAFFR CAR-T infusion.

    Determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of BAFFR-CAR T cells. The highest dose with ≤ 1/6 participants with DLT will be considered the MTD.