eligibility_summary
Inclusion: Adults ≥18 with R/R multiple myeloma, ECOG ≤2, survival ≥12 weeks, measurable disease, adequate organ function and venous access, consent. Exclusion: prior CAR‑T–interfering therapy or recent vaccines, active infections, CNS disease, autoimmune or immunodeficiency/immunosuppression, serious cardiac/pulmonary disease, other malignancy, unresolved toxicity, substance abuse/psychiatric illness, GVHD, recent CAR‑T/auto‑SCT/other trial drugs, allergy, pregnancy, investigator risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
A Phase 1/2a open-label study of KQ-2003, an autologous dual-target CAR T-cell therapy for relapsed/refractory multiple myeloma. Type: biological cellular gene therapy (patient-derived T cells genetically engineered with chimeric antigen receptors). Mechanism: KQ-2003 T cells co-express CARs against BCMA and CD19, enabling direct antigen recognition and CAR-mediated T-cell activation and cytotoxic killing of target cells, designed to limit antigen escape by covering both plasma-cell BCMA and B-lineage CD19. Targets/cells/pathways: BCMA (TNFRSF17) on malignant plasma cells/normal plasma cells, CD19 on B cells and potential myeloma progenitors, results in depletion of BCMA+/CD19+ tumor-supportive compartments. Dosing: single infusion cohorts of 1.0×10^6, 2.0×10^6, or 3.0×10^6 CAR-T cells/kg, RP2D expansion planned.