eligibility_summary
Eligibility: Ages 18-50 (1-<18 after approval), CD7+ T-ALL/T-LL in >=2nd relapse, post-HSCT relapse, or refractory after induction/re-induction (incl. T-dominant MPAL). Must be eligible for myeloablative allo-HSCT with donor. Exclusions: CNS-3/progressive or parenchymal/cranial nerve disease, active CNS dysfunction or irreversible neurotoxicity, prior CD7 therapy, or antileukemic therapy within 14 days.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05885464 tests BEAM-201, an allogeneic, multiplex base-edited anti-CD7 CAR-T cell therapy (cellular gene therapy). Mechanism: CAR-mediated cytotoxicity against CD7+ malignant T cells in r/r T-ALL/T-LL. Edits disrupt TRAC (removes TCR to limit GVHD), CD7 (prevents fratricide), PDCD1/PD-1 (reduces checkpoint inhibition), and CD52 (confers resistance to alemtuzumab). Lymphodepletion regimens: fludarabine (antimetabolite) + cyclophosphamide (alkylating agent) with or without alemtuzumab (anti-CD52 monoclonal antibody) to deplete host lymphocytes and improve CAR-T engraftment. Targets/pathways: CD7 on T-lymphoblasts, PD-1 checkpoint pathway, TCR signaling (abrogated), CD52 on host lymphocytes.