eligibility_summary
Adults ≥18. Cohort A: AML with 2nd+ relapse, post-allo MRD ≥0.1%, or refractory/relapsed >5% blasts, CD38+. Cohort B: R/R MM after ≥3 lines incl IMiD, PI, daratumumab, measurable. Transplant backup (AML donor, MM ≥2×10^6/kg CD34+). Adequate organ function, ECOG 0–1. Exclude active HBV/HCV, infections, NYHA III/IV, JAK2 V617F, active GVHD, steroid/immunosuppressant use, active CNS disease, pregnancy, autoimmune on ≥10 mg pred, or MS/optic neuritis, and allergy to HSA/DMSO/Dextran 40.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, open-label 3+3 dose escalation of CART-38: autologous T cells lentivirally engineered to express an anti‑CD38 chimeric antigen receptor with CD3ζ (TCRζ) activation and 4‑1BB (TNFRSF9) costimulatory domains. Type: gene‑modified cellular immunotherapy (CAR T). Mechanism: CAR binding to CD38 on malignant cells triggers T‑cell activation, proliferation, and cytotoxic killing via CD3ζ, 4‑1BB enhances persistence and survival. Pre‑infusion lymphodepletion uses cyclophosphamide (alkylating agent causing DNA crosslinks) and/or fludarabine (purine analog inhibiting DNA synthesis) to reduce host lymphocytes and promote CAR T expansion. Targets/cells/pathways: CD38 on AML blasts and myeloma plasma cells, T‑cell receptor signaling (CD3ζ), 4‑1BB co‑stimulation. Trial included parallel AML and MM cohorts with single IV CAR T infusion across escalating dose levels.