eligibility_summary
Adults ≥18 with progressive multiple myeloma after ≥3 lines (incl PI & IMiD) or primary plasma cell leukemia after ≥1 regimen, measurable disease (M‑protein, sFLC, or ≥5% circulating PCs), ECOG 0–2, adequate organs, survival >12 wks, contraception required. Exclude pregnancy/lactation, CNS/autoimmune disease, recent SCT/therapy/surgery/vaccines/steroids, uncontrolled infection/illness, cardiopulmonary limits, severe drug/DMSO allergy, active HBV/HCV/HIV/syphilis, unresolved ≥G2 AEs, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CT071, an autologous, gene‑modified chimeric antigen receptor T‑cell (CAR‑T) therapy (cellular biologic). First‑in‑human, single‑arm, dose‑finding study in relapsed/refractory multiple myeloma (RRMM) or primary plasma cell leukemia (PPCL). Mechanism of action: Patient T cells are engineered to express a CAR targeting GPRC5D on malignant plasma cells. Upon antigen binding, CAR signaling (via CD3ζ with costimulation) activates T cells to proliferate, release cytokines, and kill target cells through perforin/granzyme‑mediated cytotoxicity. Cells/pathways targeted: GPRC5D‑positive clonal plasma cells in MM/PPCL, activation of cytotoxic T‑cell pathways and immune synapse signaling with downstream inflammatory cytokine pathways in the tumor microenvironment.