eligibility_summary
Eligibility: Acute leukemia, age 14–65, relapsed/refractory, washout ≥2 wks or 5 half-lives (≥3 for checkpoint tx), prior toxicities ≤G1. ECOG 0–3, adequate heart (LVEF ≥50%), renal, hepatic, SpO2 >92%, life expectancy ≥3 mo, not pregnant, contraception required. Exclude: active infection (incl HIV, HBV/HCV only if PCR−), CNS disease, major cardiac disease/events, immunodeficiency, recent DVT/PE, autoimmune on immunosuppression, live vaccine ≤6 wks, other cancers <3 yrs, pregnancy/lactation, noncompliance, other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CD7 CAR‑T cells (biologic, gene‑modified cellular immunotherapy). Autologous T lymphocytes are engineered to express a chimeric antigen receptor targeting CD7 and infused IV with dose escalation (≈1×10^5–1×10^8 cells/kg). Mechanism of action: CAR binding to CD7 triggers CD3ζ/costimulatory signaling, leading to T‑cell activation, proliferation, cytokine release, and perforin/granzyme‑mediated cytolysis of CD7‑positive leukemic cells, independent of MHC. Targets: CD7 antigen on T‑lineage cells and CD7+ leukemic blasts (acute leukemia), resulting in depletion of CD7+ malignant cells (and on‑target T/NK‑cell aplasia). Study focus: safety, tolerability/MTD, and anti‑leukemia activity.