eligibility_summary
Eligibility: Adults ≥18 with newly diagnosed, measurable MM, high‑risk features (cytogenetics incl del17p/t(4,14)/1q21 gain, R‑ISS 3 or R2‑ISS 3–4, extramedullary, 2–5% peripheral plasma cells), ECOG 0–2, adequate counts, CrCl≥40, liver/coag, venous access, contraception. Exclude: non‑secretory MM, >2 VRd cycles, pregnancy/lactation, CNS disease, uncontrolled infection or HIV/HCV/HBsAg/TPPA+, recent vaccines, severe allergy to study meds/DMSO, serious cardiac/pulmonary disease, recent stroke/seizure, major surgery, unresolved >G1 AEs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: Early Phase 1, single-arm, open-label study in high‑risk newly diagnosed multiple myeloma. Intervention: CT071, an autologous chimeric antigen receptor T‑cell (CAR‑T) infusion (genetically modified T‑cell therapy). Mechanism of action: Patient T cells are engineered ex vivo to express a CAR that recognizes a myeloma‑associated surface antigen (antigen not specified). Upon antigen binding, CAR signaling (CD3ζ with costimulation) triggers T‑cell activation, proliferation, cytokine release, and cytotoxic killing (perforin/granzyme) independent of MHC, with in vivo expansion/persistence assessed by cell‑kinetic measures. Targets: Malignant plasma cells in multiple myeloma. Pathways/cells affected: CAR‑mediated T‑cell activation and effector pathways, immune synapse formation, apoptosis of target plasma cells, downstream cytokine pathways (relevant to CRS/ICANS management). Primary focus: safety, efficacy, and cell kinetics of CT071.