eligibility_summary
Include: relapsed/refractory hematologic malignancy (blasts >5% or extramedullary, incl post-transplant relapse, refractory after ≥2 inductions/salvage), CD7+ by flow/IHC, if PB tumor cells, CD4/CD8− or ≤1% otherwise. ECOG 0–2, survival >3 mo, adequate renal/hepatic/cardiopulmonary function (LVEF ≥50%, SpO2 >90%). Exclude: major cardiopulmonary disease, active GVHD, advanced cancers, uncontrolled infection, active HBV/HCV/HIV/syphilis, severe biologic allergy, serious CNS disorders, pregnancy/lactation, investigator concern.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-center, open-label phase 1/2 trial of CD7-specific CAR-T cells for CD7+ relapsed/refractory hematologic malignancies, given after fludarabine + cyclophosphamide lymphodepletion. Interventions and mechanisms: (1) CD7 CAR-T cells (autologous, lentiviral-engineered, second‑generation CAR with 4‑1BB costimulation and CD3 signaling, manufactured as CD7‑ T cells to prevent fratricide). Mechanism: CAR recognition of CD7 triggers T-cell activation and cytotoxicity with 4‑1BB–mediated persistence/expansion. (2) Fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) provide lymphodepletion/immunosuppression to enhance CAR-T engraftment. Targets: CD7 on malignant T/NK-lineage or other CD7+ tumor cells, CAR T-cell activation (CD3) and 4‑1BB pathways, host lymphocytes for depletion.