eligibility_summary
Inclusion: Severe aplastic anemia per 2017 Chinese criteria, suitable related haplo donor, not eligible/willing for standard allo‑HSCT, adequate organs (CrCl >60, acceptable liver tests, LVEF ≥50%, no lung infection, SpO2 ≥92%), ECOG 0–1, life expectancy ≥3 mo, contraception, consent. Exclusion: GVHD or treatment ≤4 wks, CNS disease, QT prolongation/severe heart disease, <100 d post‑HSCT, HIV/HBV/HCV or active infection, chemo ≤2 wks, allergy to pre‑tx, poor CD3/28 expansion, other high‑risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06633328 (Early Phase 1, single-arm). Interventions: 1) Donor-derived CD7 CAR-T cells (cellular gene-modified immunotherapy). Mechanism: T cells engineered with an anti-CD7 chimeric antigen receptor selectively eliminate CD7-expressing lymphocytes (primarily pathogenic/autoreactive T cells and some NK cells), aiming to suppress immune-mediated marrow destruction and provide deep lymphodepletion before transplant. 2) Allogeneic hematopoietic stem cell transplantation (allo-HSCT). Mechanism: replaces the failed marrow with donor stem cells to restore hematopoiesis and reconstitute immune tolerance. Targets/cells/pathways: CD7 on T cells (and NK cells), depletion of autoreactive cytotoxic T-cell activity against hematopoietic stem/progenitor cells, subsequent donor HSPC engraftment and immune reset. Primary focus: safety (DLT, TEAEs) in severe aplastic anemia.