eligibility_summary
Eligible: Adults (≥18) with CD19+ B‑cell NHL/CLL/SLL after ≥2 therapies (Phase Ib: CLL/SLL), ECOG 0–1, >4‑mo life expectancy, adequate organs, candidate for TBI‑2001 within 3 mo, bridging per SOP, targeted/biologic allowed with approval. Exclude: uncontrolled illness, autoimmune ≤2y, immunodeficiency/transplant, hypersensitivity, active/untreated CNS mets, malignancy ≤2y, immunosuppression ≤14d, TB/HIV/HTLV/syphilis/active HBV/HCV, pregnancy, prior allo‑HSCT or CD19 therapy, live vaccine <28d.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05963217 tests TBI-2001, an autologous CD19-directed CAR-T cell therapy (genetically engineered, retroviral transduction). The CAR includes costimulatory domains that enhance cytokine-driven JAK/STAT signaling, promoting T-cell activation, proliferation, and cytotoxic killing of target cells. Patients receive lymphodepletion with cyclophosphamide (alkylating agent) and fludarabine (purine analog antimetabolite) to reduce host lymphocytes and support CAR-T expansion. Targets: CD19 on malignant B cells (B-cell NHL, CLL/SLL), signaling pathways engaged include CD3ζ and costimulatory domain–mediated JAK/STAT. Phase I/Ib, 3+3 dose escalation (0.3–3×10^6 CAR-T cells/kg).