eligibility_summary
Inclusion: B-ALL with CD19 and/or CD22. Ages 1–29: relapsed/refractory after ≥3 lines or post–allo-HCT, prior CD19 CAR-T unless CD19 lost or ineligible, PS ≥60% (Lansky/Karnofsky) or ECOG 0–1. Ages ≥30: R/R after allo-HCT or ≥2 lines (incl blina/inotuzumab), or primary refractory, or first relapse ≤12 mo, ECOG 0–1. Exclusion: allo-HCT <12 wks, isolated extramedullary/testicular/bulky disease, marrow-failure syndromes, Burkitt, active neuro-autoimmune/inflammatory.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: IMJ995, an autologous, gene‑modified CAR‑T cell therapy (single IV infusion) manufactured via the T‑Charge process. Mechanism of action: Patient T cells are engineered to express chimeric antigen receptors that bind CD19 and CD22, CAR engagement triggers CD3ζ/co‑stimulatory signaling, leading to T‑cell activation, expansion, cytokine release, and cytotoxic killing of target B cells. Targets: Malignant B‑lineage lymphoblasts expressing CD19 (B‑cell receptor co‑receptor) and/or CD22 (Siglec‑2) on the cell surface, pathway focus is CAR‑mediated T‑cell effector signaling against B‑ALL. Trial: Phase I, first‑in‑human, single‑agent in pediatric and adult R/R ALL, status withdrawn (sponsor decision).