eligibility_summary
Inclusion: ≥18, CD19+ B-ALL, marrow blasts ≥5%, R/R (refractory ≥2 lines or relapsed: early, late poor response, ≥2 relapses, or post-allo-HSCT), Ph+ if R/R after ≥2 TKIs or TKI-intolerant/T315i, ECOG 0–1, survival >12 wks, adequate organs, apheresis-eligible, contraception. Exclusion: isolated EMD, active CNS-2/3, prior CAR-T, recent tx/radiation, HBV/HCV/HIV/CMV, major cardiac disease, infection, GVHD/autoimmune, recent stroke/seizure/VTE, unctrl HTN, live vaccine ≤4 w, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I, single-arm, dose-escalation study in adults with relapsed/refractory CD19+ B-ALL evaluating MC-1-50, a biological, gene-modified autologous CD19-directed CAR‑T cell therapy made on the PrimeCAR platform (~3-day manufacturing) with high T‑naive content. After lymphodepletion, a single IV infusion is given at 1×10^5–5×10^5 CAR+ cells/kg (max 5×10^7). Mechanism: engineered T cells expressing a chimeric antigen receptor recognize CD19 on B cells, leading to CAR-mediated TCR/co-stimulatory signaling, T‑cell activation, cytokine release, and cytotoxic killing, resulting in depletion of CD19+ malignant (and normal) B cells. Targets: CD19 antigen on B‑lineage leukemia cells, pathways include CAR signaling and downstream immune effector functions. Primary aims: safety, tolerability, cytokinetics, and preliminary efficacy.