eligibility_summary
Eligibility: r/r CD5+ T‑ALL (no CR, CR ≤12 mo, refractory or multiple relapses), CD5 >90%, marrow blasts >5% (morph) or >1% (flow), adequate organs (TBili ≤51, ALT/AST ≤3×ULN, Cr ≤176.8 µmol/L), LVEF ≥50%, SpO2 ≥92%, ECOG 0–2, life ≥12 wks, consent, contraception ≥6 mo if fertile. Exclude CNS disease, QT prolongation/severe heart disease, active HBV/HCV/HEV or infection, prior gene therapy, recent therapy (steroids/SMT ≤72h, chemo ≤2w, RT ≤4w), poor T‑cell proliferation, or investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CD5 CAR T-cells (biological, cellular immunotherapy). Engineered T cells express a chimeric antigen receptor that binds CD5 on leukemic cells, CAR engagement activates CD3ζ (with costimulation) to drive T-cell activation, proliferation, cytokine release, and perforin/granzyme-mediated cytotoxicity, killing targets in an HLA-independent manner. Target cells/pathways: CD5+ T-ALL blasts (and potentially normal CD5+ T cells), leading to depletion of CD5-expressing T-cell populations, engages CAR signaling pathways in the infused T cells and triggers apoptosis/cytolysis pathways in CD5+ leukemia cells. Early Phase 1, single-arm, 3+3 dose escalation, IV infusion for r/r CD5+ T-ALL.