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Clinical Trials in the USA / NCT05370430
Recruiting Phase 1

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

NCT05370430 · tracked via the Priya Life Science USA tracker
Sponsor
PeproMene Bio, Inc.
Phase
Phase 1
Started
2022-06-13
Last updated
2025-11-20

Condition(s) studied

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

Investigational drug(s) / intervention(s)

BAFFR-CAR T cells

BAFFR-CAR T cells: First-in-human trial examining the safety and preliminary efficacy of BAFFR-CAR T cells in participants with r/r B-NHL

Study summary

A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
City of Hope Medical Center Duarte California Recruiting
Stanford University Stanford California Recruiting
University of Kansas Hospital Kansas City Kansas Recruiting
University of Minnesota Minneapolis Minnesota Recruiting
Atrium Health Levine Cancer Institute - Morehead Charlotte North Carolina Recruiting
Providence Swedish Cancer Institute Seattle Washington Recruiting

More PeproMene Bio, Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05370430 on ClinicalTrials.gov ↗ ← All trials in the USA