eligibility_summary
Eligible: Patients with multiple myeloma, leukemia, or lymphoma receiving lymphodepleting chemotherapy before commercial CAR-T, adequate marrow function, renal function <=60 mL/min/1.73 m2, ECOG 0-2. Exclude: relative CNS disorders, active uncontrolled infection or other conditions that may interfere per investigator, use of therapeutic-dose systemic steroids (>20 mg/day prednisone equivalent) within 72 hours before CAR-T.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05909059 tests dose-adjusted lymphodepleting chemotherapy before commercial CAR T-cell therapy in adults with moderate–severe renal dysfunction (B‑cell NHL, MM, adult ALL). Interventions: fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent). Mechanisms: both induce DNA damage/replication blockade leading to lymphocyte depletion, this immunosuppression creates “space” and cytokine support to enhance CAR T expansion/persistence. Dosing: given IV Days −5 to −3, fludarabine reduced by 20% (moderate), 40% (severe), 50% (dialysis), cyclophosphamide no reduction except 25% in dialysis. Targets: host lymphocytes (T/B cells) via DNA synthesis/crosslinking pathways, subsequent CAR T cells target the patient’s lymphoid/plasma cell malignancy per standard commercial product. Phase 2, single-group, feasibility/tolerability.