eligibility_summary
Adults ≥18, ECOG ≤2, B-ALL in first CR but MRD+ (Ph−: ≥0.01% by FACS/NGS ≥28 d post-induction with multi-agent chemo, Ph+: same or not CMR ≥57 d after TKI+chemo). CD3 >0.15×10^6/mL, adequate organs (ANC ≥500, Plt ≥50k), ≤G2 tox. Exclude prior CAR-T, R/R ALL, MPAL/Burkitt, active CNS, major cardiac disease, uncontrolled infection, HIV/HBV/HCV, unstable VTE, planned pregnancy. Apheresis/LD/infusion require stability, Ph+ may start TKI after Day 42 if ANC >1000, Plt >50k.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05535855 (Phase 1/1b). Intervention: UCD19, an autologous, gene‑modified CD19‑directed CAR T‑cell therapy, given after lymphodepleting chemotherapy, Ph+ patients may start a BCR‑ABL1 TKI after day 42. Mechanism/type: Cellular immunotherapy, patient T cells are lentivirally transduced to express a CAR with an anti‑CD19 scFv, enabling antigen‑specific recognition and activation of cytotoxic T‑cell killing of CD19+ cells. Targets (cells/pathways): CD19 on B‑cell lineage (malignant B‑ALL blasts and normal B cells), leading to B‑cell depletion (B‑cell aplasia) and MRD eradication, activation of T‑cell effector pathways via CAR signaling. For Ph+ ALL, optional post‑CAR T TKI targets BCR‑ABL1 kinase signaling. Primary focus: safety/MTD, expansion to assess preliminary efficacy.