eligibility_summary
Eligible: 18–70, consented, R/R B‑ALL or B‑NHL (DLBCL‑NOS, PMBCL, TFL, MCL, HGBL, CLL/SLL) after standard therapy ± transplant, Ph+ ALL after ≥2 TKIs/intolerant, ALL blasts ≥5%, ECOG ≤2, ≥12‑wk life expectancy, adequate labs/organ and cardiac function, SpO2>92%. Exclude: active CNS disease/lymphoma, serious infection (HBV/HCV/HIV/syphilis), prior CD19 therapy or any CAR‑T, recent anti‑cancer or GVHD therapy, active GVHD/autoimmunity, recent MI/PE/DVT, marrow‑failure syndromes, pregnancy, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: anti-CD19 CAR-T cells (biological, autologous, genetically engineered T‑cell therapy). Single IV infusion with 3+3 dose escalation (1×10^5, 3×10^5, 1×10^6 CAR+ cells/kg) after lymphodepleting pre-treatment. Mechanism of action: a CAR bearing an anti‑CD19 scFv redirects patient T cells to recognize CD19 on B cells and, via CAR signaling, triggers T‑cell activation, proliferation, cytokine release, and perforin/granzyme‑mediated cytotoxic killing, expected on‑target effect includes depletion of normal CD19+ B cells. Targets: CD19 antigen on malignant B cells in R/R B‑ALL, DLBCL/PMBCL, transformed FL, mantle cell lymphoma, high‑grade B‑cell lymphoma, and CLL/SLL. Pathways/biomarkers monitored: CAR‑T cellular kinetics and systemic inflammatory response (ferritin, CRP, and related cytokines).