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

Korábbi kezelés

• Prior Therapies \& Transplants:
  • Prior allogeneic SCT.
  • Autologous SCT < 6 months before leukapheresis.
  • Concurrent systemic steroids or chronic immunosuppressant use.

Más betegség

• Disease-Specific Exclusions:
  • Cardiac lymphoma involvement.
  • Need for urgent therapy due to tumor-related complications (e.g., bowel obstruction).

Életkor

• 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.

Egyéb

• Pregnancy \& Breastfeeding: Females who are pregnant or nursing.
• Other Considerations:
  • Investigator-determined safety concerns.
  • Potential noncompliance with study procedures.

• 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.