eligibility_summary
Eligible: adults (≥18) with histologically confirmed multiple myeloma and renal insufficiency (eGFR<45 MDRD), ECOG ≤1, meet FDA SOC for cilta‑cel, use contraception, and provide consent. Exclude: malignancy confounding assessment, other investigational agents, uncontrolled illness, cardiac status worse than NYHA 2B, pregnancy/breastfeeding (WOCBP negative test ≤14 days), and HIV/HBV/HCV with detectable viremia (suppressed/undetectable allowed).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests a lymphodepleting regimen of low-dose total body irradiation (TBI) plus cyclophosphamide before ciltacabtagene autoleucel (Carvykti, cilta-cel) in relapsed/refractory multiple myeloma with impaired renal function. Interventions/mechanisms: • Cyclophosphamide: alkylating chemotherapy (nitrogen mustard) that DNA-crosslinks and immunosuppresses, depleting host lymphocytes (including T/B cells and Tregs) to facilitate CAR T expansion. • TBI: low-dose whole-body external beam radiation causing cytotoxic/lymphodepleting effects and reducing cytokine sinks. • Cilta-cel: autologous, gene-modified BCMA-directed CAR T-cell therapy (dual-epitope BCMA binder) that recognizes BCMA on malignant plasma cells, triggering T-cell activation and cytolysis. Targets: BCMA-expressing myeloma plasma cells, host lymphocyte compartments/pathways for lymphodepletion.