eligibility_summary
Adults ≥18 with B-ALL or B-NHL. B-NHL: ≥2nd relapse (CD20-treated), refractory/relapse ≤1 yr after 1st-line, or relapse ≤1 yr post auto-HSCT. B-ALL: relapse ≤12 mo after CR1, relapse after 2nd-line or auto-HSCT, induction failure (no CR/CRi), Ph+ after ≥2 TKIs/intolerant. ECOG 0-2, life ≥12 wks, adequate organs. Exclude: recent disallowed therapies, HBV/HCV/infection, uncontrolled comorbidity, bleeding/VTE, autoimmune/CNS disease, pregnancy/lactation, ≥Gr2 tox (except alopecia/Gr2 neuropathy), PI judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06445803 tests KQ-2002, an autologous, genetically engineered CAR-T cell therapy that dual-targets CD19 and CD22 in adults with R/R CD19+ B-ALL or B-NHL. Mechanism: patient T cells are transduced to express a CAR recognizing CD19/CD22 on B cells, CAR engagement triggers T-cell activation, cytokine release, and cytolytic killing, depleting malignant B cells (B-cell aplasia). Preconditioning lymphodepletion uses fludarabine (purine analog, DNA synthesis inhibitor) and cyclophosphamide (alkylating agent) to reduce host lymphocytes and support CAR-T expansion. Targets/pathways: CD19 and CD22 B-cell antigens (BCR co-receptor/inhibitory receptor) on malignant B cells.