Adebrelimab Combined With SHR2554 in Relapsed/Refractory PTCL and NK/T-Cell Lymphoma

This is a single-arm, multicenter, Phase Ib/II clinical study consisting of two parts: a Phase Ib safety lead-in phase and a Phase II expansion phase. Phase Ib is the safety lead-in phase. The primary objective is to determine the Recommended Phase 2 Dose (RP2D) based on dose-limiting toxicities (DLTs). It plans to enroll 6 subjects to observe the safety of SHR2554 (350 mg, twice daily) combined with adebrelimab (600 mg or 1200 mg) after 1 treatment cycle. If \< 2 DLTs occur, the RP2D for adebrelimab will be 1200 mg; if ≥ 2 DLTs occur, the RP2D will be 600 mg. Phase II is the expansion phase, utilizing an induction treatment of 6 cycles of SHR2554 twice daily combined with adebrelimab at the RP2D administered via intravenous infusion once every 3 weeks. All patients achieving a Complete Response (CR) or Partial Response (PR) after induction treatment will receive SHR2554 maintenance therapy (28 days per cycle) until disease progression or treatment discontinuation due to other reasons. The duration of SHR2554 administration during the maintenance phase will not exceed 24 months. The primary objective is to evaluate the efficacy of the combination regimen, with a planned enrollment of 40 subjects. If the RP2D for adebrelimab is determined to be 1200 mg, the 6 subjects from the safety lead-in phase will also be included in the Phase II analysis.