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