eligibility_summary
Inclusion: Adults (≥18), Chinese, ECOG 0–1, SAA relapsed/refractory or HSCT-ineligible, life expectancy ≥3 mo, adequate labs/oxygen, venous access, no apheresis contraindication, negative pregnancy test, 36‑mo contraception, investigator deems benefit>risk, able to consent. Exclusion: recent other cancers, serious cardiac disease or LVEF<50%, HIV/HBV/HCV/syphilis/CMV+, pregnant/lactating, hypersensitivity incl DMSO/biologics or F/C contraindication, substance/psychiatric issues, other unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Autologous CD7-directed CAR-T cell infusion (cellular gene therapy, patient T cells collected and retrovirally transduced with an anti‑CD7 CAR) following lymphodepletion with fludarabine (purine‑analog antimetabolite) and cyclophosphamide (DNA‑alkylating agent). Mechanisms: CD7-CAR-T cells recognize CD7 on T-lineage cells (and some NK cells) and induce CAR-mediated cytotoxicity, depleting pathogenic CD7+ autoreactive lymphocytes that drive immune-mediated destruction of hematopoietic stem/progenitor cells, aiming to reset immunity and restore hematopoiesis. Lymphodepletion reduces host lymphocytes and supports CAR-T expansion/persistence. Cells/pathways targeted: CD7+ T cells (and NK cells), CAR/TCR signaling, cytotoxic effector and inflammatory cytokine pathways.