eligibility_summary
Eligibility: Adults (≥18) with relapsed/refractory B‑cell malignancy, ECOG 0–1, adequate renal/hepatic/cardiac/pulmonary function, agree to contraception through 12 months post‑CTX112. Exclude: prior allogeneic HSCT, CNS disease (malignancy or seizure/stroke/dementia/cerebellar/autoimmune CNS), uncontrolled infection/IV anti‑infectives, active HIV/HBV/HCV, recent cancers (≤3y) except low‑risk, recent systemic anticancer therapy, primary immunodeficiency/active autoimmune needing steroids, pregnant/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05643742 (Phase 1/2). Intervention: CTX112, an allogeneic, CD19-directed CAR T-cell therapy (biological, cell-based immunotherapy) engineered ex vivo using CRISPR-Cas9. Administration: Single IV infusion after lymphodepleting chemotherapy. Mechanism of action: Donor T cells are modified to express a chimeric antigen receptor that recognizes CD19 on B cells, CAR engagement activates T-cell cytotoxic pathways (e.g., perforin/granzyme release and cytokine-mediated killing), leading to targeted lysis of malignant B cells. Targets: CD19-expressing B cells in relapsed/refractory B-cell malignancies (e.g., NHL subtypes, CLL/SLL), key pathways involved are CAR-mediated T-cell activation and cytotoxic effector functions. Purpose: Evaluate safety and efficacy in R/R B-cell malignancies.