eligibility_summary
Eligibility: 18–75 with RRMM after ≥3 prior lines (PI, IMiD, anti‑CD38), recent progression, measurable disease, ECOG 0–2, SpO2 ≥95%, adequate labs, fit for lymphodepletion, prior BCMA/GPRC5D allowed, contraception and consent required. Exclude: pregnancy, active HBV/HCV/HIV/syphilis, major CV/pulm/CNS disease, ILD, recent steroids/anticancer tx/surgery/live vaccine, other cancer <3y, planned ASCT, allergy, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: ACT-001, an allogeneic (off‑the‑shelf) bispecific CAR‑NK cell therapy (biological/cell therapy). It delivers NK cells engineered with chimeric antigen receptors that recognize both BCMA and GPRC5D, enabling dual‑antigen targeting to enhance tumor kill and mitigate antigen escape. Single infusion at 1×10^8, 3×10^8, or 9×10^8 cells after lymphodepletion (cyclophosphamide/fludarabine). Mechanism of action: Upon CAR engagement of BCMA or GPRC5D on myeloma cells, NK cells are activated to mediate cytotoxicity (perforin/granzyme, cytokine release) and induce apoptosis. Targets/cells/pathways: Malignant plasma cells in multiple myeloma expressing BCMA (TNFRSF17, BAFF/APRIL survival axis) and/or GPRC5D (GPCR).