eligibility_summary
Adults (≥18) with CD19+ r/r ALL after ≥2 lines (alloHCT counts if >100 d), ECOG 0–2/KPS≥70, adequate organ function, negative/undetectable HIV/HBV/HCV, not pregnant, consent/contraception. CNS, MRD or extramedullary disease allowed. Meet washouts, clinically stable for apheresis, lymphodepletion, infusion. Exclude: alloHCT<100 d, prior CAR‑T<90 d/BAFFR‑CAR‑T, CNS disease, GVHD/autoimmune on immunosuppression, NYHA III/IV, uncontrolled infection/illness, high-dose steroids, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase Ib trial testing humanized CD19-specific CAR T cells (CD19CAR‑CD28‑CD3ζ‑EGFRt, naïve/memory T‑cell–enriched) after fludarabine/cyclophosphamide lymphodepletion in adults with r/r CD19+ B‑ALL. Interventions/mechanisms: autologous CAR T (cellular gene therapy) whose humanized scFv binds CD19 and signals via CD28+CD3ζ to kill and expand, EGFRt tag enables on‑demand ablation. Fludarabine (purine‑analog antimetabolite) and cyclophosphamide (DNA‑alkylating agent) provide cytoreduction/lymphodepletion to enhance CAR T expansion. Optional cetuximab (chimeric anti‑EGFR IgG1 mAb) ablates EGFRt‑tagged CAR T, optional alloHCT. Targets/pathways: CD19 on malignant/normal B cells (B‑cell aplasia), T‑cell activation via CD28/CD3ζ, DNA synthesis/crosslinking for lymphodepletion, EGFRt safety switch.