eligibility_summary
Eligible: 1–30 yrs with R/R CD19+ B‑ALL or B‑cell lymphoma lacking curative options, Ph+ after ≥2 lines incl TKI, measurable disease, post auto/allo SCT OK per criteria, prior anti‑CD19/22 CAR OK, PS ≥50%, adequate marrow and organs, CNS1–2, not pregnant, agree to contraception, consent. Exclude: isolated testicular ALL, CNS3 or CNS lymphoma, blasts ≥50k/rapid PD, uncontrolled infection or active HIV/HBV/HCV, recent major cardiac disease, autoimmune disease, recent other cancer, poor compliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: EB-BH2024, a fourth-generation, dual-target autologous CAR T-cell therapy (biological, gene-modified T cells) against CD19 and CD22, given after lymphodepleting chemotherapy (fludarabine, a purine analog antimetabolite, cyclophosphamide, an alkylating agent). Optional repeat CAR-T doses for responders. Mechanism: CAR-T cells recognize CD19/CD22 on malignant B cells, activating T-cell signaling and cytotoxic killing, lymphodepletion promotes CAR-T expansion/persistence. Targets: CD19 and CD22 antigens on B-cell malignancies, including marrow, nodal, and CNS disease in B-ALL, DLBCL/other B-cell lymphomas, CLL, and MRD-positive states. Primary aims: safety, PK, and dose/reinfusion optimization. Open-label, single-arm phase I/II.