SINGAPORE, Aug 18 (Bernama-GLOBE NEWSWIRE) — Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, today announced the dosing of the first patient in a Phase 1b clinical trial investigating TT11, the company’s autologous CD30 chimeric antigen receptor T-cell (CAR-T) therapy, in combination with Bristol Myers Squibb’s nivolumab as a potential second-line treatment for patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma (cHL).
The Phase 1b open-label trial (ACTION; NCT05352828) will enroll up to 14 patients with CD30+ cHL with relapsed or refractory disease after front-line therapy combining PD-1 antibody and CAR-T therapy in a “sandwich” study design. Patients will initially receive two cycles of nivolumab dosed at four-week intervals followed by lymphocyte depleting treatment with fludarabine/bendamustine chemotherapy. Patients will then receive a single infusion of TT11, followed by two additional cycles of nivolumab. The primary endpoint of the trial is safety and tolerability of the combination regimen. Secondary endpoints will evaluate key efficacy indicators including overall response rate, duration of response, and progression-free survival.