eligibility_summary
Inclusion: Consent, active BCMA+ multiple myeloma (≥5% by flow), relapsed/refractory after ≥2 cycles or post‑ASCT, ECOG 0–2, and either age ≥50 or unsuitable/failed autologous CAR‑T (T‑cell sep/exp failure, PBMC T cells <10%, or rapid progression). Exclusion: pregnant/nursing (WOCBP negative test ≤48h pre‑conditioning), active HIV/syphilis/HBV/HCV, significant liver dysfunction, recent lymphotoxic chemo, severe cardiac/renal disease or serious mental disorder, recent trial/prior gene therapy, cyclophosphamide/fludarabine contraindication.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: PD1-BCMA-CART — an autologous, gene-edited CAR T-cell therapy (biological). The CAR specifically recognizes BCMA on myeloma cells. The construct is integrated non-virally in a site-directed manner, associated with the PD-1 locus to modulate/abrogate PD-1 signaling, aiming to reduce T-cell exhaustion and enhance antitumor activity. Mechanism of action: Ex vivo–expanded CAR T cells bind BCMA, activate cytotoxic T-cell responses, and kill BCMA+ malignant plasma cells, PD-1 pathway modulation counters PD-1/PD-L1–mediated immunosuppression to improve persistence and efficacy. Targets: BCMA-expressing myeloma cells, PD-1/PD-L1 checkpoint pathway in T cells.