BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL
A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)
Inclusion Criteria
- Informed Consent: Signed informed consent by the participant or legally authorized representative.
- Age & Performance Status:
- Age ≥ 18 years
- ECOG performance status ≤ 2
- 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.
- Measurable Disease: Tumor ≥1.5 cm on CT/PET scan or evidence of disease in blood, BM, GI, skin, or spleen.
- Prior CAR T-cell Therapy: Allowed if ≥ 3 months since last treatment and CD19 CAR-T persistence < 5% before leukapheresis.
- 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.
- Infectious Disease Screening: Seronegative for HIV, active HBV, active HCV (or undetectable viral load if positive).
- Reproductive Considerations:
- Negative pregnancy test for females of childbearing potential.
- Use of effective contraception or abstinence through 3 months post-treatment.
Exclusion Criteria
- Prior Therapies & Transplants:
- Prior allogeneic SCT.
- Autologous SCT < 6 months before leukapheresis.
- Concurrent systemic steroids or chronic immunosuppressant use.
- Disease-Specific Exclusions:
- Cardiac lymphoma involvement.
- Need for urgent therapy due to tumor-related complications (e.g., bowel obstruction).
- 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.
- Pregnancy & Breastfeeding: Females who are pregnant or nursing.
- Other Considerations:
- Investigator-determined safety concerns.
- Potential noncompliance with study procedures.
Additional locations may be listed on ClinicalTrials.gov for NCT05370430.
Locations matching your search criteria
United States
California
Duarte
Palo Alto
Minnesota
Minneapolis
North Carolina
Charlotte
This phase I trial evaluates the side effects and best dose of BAFFR-CAR T cells in
treating patients with B-cell Non-Hodgkin's Lymphoma (B-NHL) that has come back
(recurrent) or does not respond to treatment (refractory). T cells are infection fighting
blood cells that can kill cancer cells. The T cells given in this study will come from
the patient and will have a new gene put in them that makes them able to recognize BAFFR,
a protein on the surface of cancer cells. These BAFFR-specific T cells may help the
body's immune system identify and kill BAFFR+ cancer cells.
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationPeproMene Bio, Inc.
- Primary IDPMB-102
- Secondary IDsNCI-2022-07005, PMB-BAFFR-102
- ClinicalTrials.gov IDNCT05370430