eligibility_summary
Include: 18–70, ECOG 0–1, >3‑mo survival, BT‑001–positive advanced/metastatic solid tumor, measurable (RECIST), largest lesion <4 cm, adequate marrow/organ function and O2, contraception. Exclude: recent anti‑cancer therapy (per window), prior BT‑001 or CAR‑T/TCR‑T/vaccine, symptomatic brain mets, pregnancy/breastfeeding, key drug allergies, active HBV/HCV/HIV/immunodeficiency, ILD/lung mets ≥3 cm, infection/recent surgery, unresolved ≥G2 AEs, recent serious CV/CNS events, systemic steroids, autoimmune/Crohn’s, unstable psych, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: B4T2-001 autologous CAR-T (lentiviral-transduced, gene-modified T-cell therapy). Mechanism: engineered CAR redirects patient T cells to bind the BT-001 tumor surface antigen and kill tumor cells via antigen-triggered T-cell activation and cytotoxicity, multiple IV infusions given without lymphodepleting chemotherapy. Supportive care: prophylactic tocilizumab (anti–IL-6 receptor monoclonal antibody) to mitigate cytokine release syndrome. Targets: BT-001–positive solid tumor cells (e.g., gastric/GEJ, pancreatic, NSCLC, CRC, metastatic breast). Pathways/cells engaged: tumor cell surface BT-001 antigen, CAR-mediated TCR/CD3ζ co-stimulatory signaling in T cells, downstream inflammatory cytokine pathways (notably IL-6) related to CRS. Phase: single-arm, dose-escalation/expansion (Phase 1).