eligibility_summary
Inclusion: 18–69, WHO 2022 relapsed/refractory B‑ALL or AML (incl. post‑CAR‑T failure), life expectancy >12 wks, ECOG ≤2, LVEF ≥50%, ≤G1 dyspnea, TBil ≤3×ULN, AST/ALT ≤5×ULN, Cr ≤1.6 mg/dL, negative pregnancy test/contraception, consent/compliance. Exclusion: severe CNS disease, NYHA III–IV, recent unstable CV events, DIC, major autoimmune/immunodeficiency or active GVHD, ongoing steroids, active HBV/HCV/HIV/syphilis/other infection, other active cancer (exceptions), uncontrolled comorbidity, unresolved ≥G2 immune AEs, recent immunosuppressants/vaccine/surgery, product allergy, other high‑risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial tests Hema-NeoTIL01, an autologous cellular immunotherapy (biologic) consisting of tumor-specific T cells (TIL-like) harvested from the patient’s bone marrow or peripheral blood and expanded ex vivo via antigen presentation. Mechanism: TCR-mediated recognition of leukemia neoantigens/leukemia-associated antigens and cytotoxic killing (perforin/granzyme) of malignant blasts after IV infusion, single-arm 3+3 dose-escalation with repeat dosing. Targets: leukemic blasts in relapsed/refractory B-ALL and AML, primarily in bone marrow. Key pathways: HLA antigen presentation to TCR, T-cell activation, clonal expansion, and cytotoxic effector functions. Includes patients relapsing after or refractory to prior CAR-T.