eligibility_summary
Adults ≥18 with R/R CD20+ B‑NHL (BM allowed), measurable disease, ≥2 prior lines, ≤1 prior CAR‑T/other gene‑modified T, ECOG 0–1, adequate organs, ALC≥300, ANC≥500, Plt≥50k, not pregnant, contraception. Part B: CD20+ R/R B‑ALL (incl Ph+) or Burkitt. Exclude: CNS‑only/secondary CNS, CLL/SLL/cutaneous, other cancer not in remission ≥3y, GVHD, recent DLI, autoimmune on IS<2y, cardiac dz <12mo, active/uncontrolled infection, vaccine <4wk, hypersensitivity, pregnancy/nursing.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: INT2104, an in vivo gene therapy (lentiviral vector) delivering a CD20-specific chimeric antigen receptor (CAR20) transgene. After a single IV infusion, the vector transduces the patient’s immune cells to generate CAR-T and CAR-NK cells in the body. Mechanism: CAR20 on T/NK cells binds CD20 on malignant B cells, triggering immune-synapse formation and cytotoxic effector pathways (perforin/granzyme release and cytokine-mediated killing), leading to depletion of CD20+ tumor cells. Targets: CD20 on B-cell malignancies, effector cell populations are autologous T cells and natural killer cells. Population: adults with relapsed/refractory CD20+ B-NHL and, in Part B, CD20+ B-ALL/Burkitt’s. Phase 1, dose escalation/confirmation focused on safety and preliminary efficacy.