eligibility_summary
Eligibility: ≥18, ECOG 0–2, measurable disease. MM: rel/ref after ≥2 lines incl IMiD, PI, anti‑CD38/SLAMF7, prior BCMA OK. Or DLBCL: rel/ref post standard therapy/HDT‑ASCT/allo‑SCT or anti‑CD19 CAR‑T. No better SOC options. Adequate organ function, contraception. Exclude: CNS/neurologic risk, O2‑dependent lung disease, dialysis, active infections (HIV, HBV/HCV, recent COVID), GVHD/immunosuppression, rapid decline, recent therapy/investigational drugs/live vaccines, pregnant/breastfeeding, hypersensitivity, fludarabine/cyclophosphamide contraindication, other active cancer, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: MDC-CAR-BCMA001, a high‑affinity autologous BCMA‑targeting chimeric antigen receptor (CAR) T‑cell therapy (genetically modified cellular immunotherapy), given as a single IV infusion after lymphodepleting chemotherapy (e.g., fludarabine/cyclophosphamide). Mechanism: patient T cells are engineered to express a CAR that binds BCMA (TNFRSF17) on malignant B‑lineage cells, CAR engagement activates T‑cell signaling (CD3ζ with costimulation), inducing cytotoxic killing and cytokine‑mediated antitumor effects. Targets: BCMA‑expressing plasma cells/late B cells in relapsed/refractory multiple myeloma and DLBCL. Pathways: BCMA–APRIL/BAFF survival axis in B/plasma cells. Phase I dose‑escalation to define safety/MTD.