eligibility_summary
Adults ≥18 with relapsed/refractory CD19+ B‑cell malignancies (CLL/SLL, FL, MCL, MZL, LBCL/Richter) after ≥2 prior lines (incl CD20±BTK per disease), BAFF‑R+, measurable disease, ECOG 0–2, adequate blood counts/organ function, EF ≥45%, room‑air O2 >92%, ≥100‑day washout after prior CD19 CAR‑T. Exclude: solid organ tx, major cardiac/CNS disease, prior anti‑BAFF‑R, active infection (HBV/HCV/HIV), recent HCT/therapy, pregnancy, uncontrolled illness, auto‑HCT candidates, life expectancy <6 wks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: MC10029, an autologous BAFFR-targeting chimeric antigen receptor (CAR) T-cell therapy, infused after lymphodepletion with fludarabine + cyclophosphamide or bendamustine. Mechanisms: Patient T cells are gene-modified to express a CAR that binds the B-cell activating factor receptor (BAFFR/TNFRSF13C) on malignant B cells, leading to T-cell activation and cytotoxic killing. Lymphodepleting agents—fludarabine (purine analog antimetabolite) and cyclophosphamide or bendamustine (alkylating agents)—debulk tumor and suppress host lymphocytes to enhance CAR-T expansion/persistence. Targets: BAFFR-expressing B cells in CLL/SLL, DLBCL, FL, MCL, MZL, and Richter transformation, BAFF/BAFFR survival signaling (e.g., NF-κB-driven B-cell survival pathways).