eligibility_summary
Inclusion: R/R B‑cell malignancy, age 2–75, measurable disease, ECOG 0–2, >12‑wk survival, adequate organ function, contraception & consent. Exclusion: other active cancer/serious psych, marrow‑failure syndromes, grade II–IV or extensive chronic GVHD, major heart disease <1 yr, non‑CVC drains, HIV+, active HBV/HCV, serious infections/allergy, autoimmune w/ organ damage or recent IS, ILD, recent trial (≤4 wks)/DLI (≤6 wks), poor adherence, Cy/Flu contraindication, steroids/IS needed, pregnant/lactating, investigator‑deemed unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-site, open-label phase 1/2 dose-escalation trial of OlyCAR-019, an autologous anti-CD19 CAR-T cell therapy produced via the OlyCAR rapid manufacturing platform, in relapsed/refractory CD19+ B-cell malignancies (leukemia/lymphoma). Intervention: single IV infusion of OlyCAR-019 at 0.5–6×10^6 cells/kg. Type: cellular gene therapy/adoptive T-cell therapy. Mechanism of action: patient T cells are genetically engineered to express a CAR with an anti-CD19 scFv, CAR engagement of CD19 triggers T-cell activation and cytotoxic effector functions, eliminating CD19+ malignant cells and causing on-target B-cell depletion. Targets: CD19 on B-lineage cells, pathways: CAR-mediated T-cell activation and cytotoxicity. Primary aim: feasibility, safety, and antitumor activity.