Efficacy and Safety of SHR0302 in Patients With Relapsed/Refractory Peripheral T/NK Cell Lymphoma
This is a non-randomized, open-label, Phase 1b clinical study to evaluate the safety, tolerability and anti-tumor efficacy of SHR0302 as monotherapy in patients with relapsed/refractory peripheral T/NK cell lymphoma. Around 7-18 patients will be subsequently enrolled into 3 different dose ascending cohorts. Additional 12-18 patients may be enrolled to further explore a selected dose defined by dose escalation cohorts.
• Age ≥ 18;
• Pathologically confirmed T or NK cell lymphoma at the enrolling institution;
• Measurable disease;
• Relapse or refractory disease after at least 1 systemic therapy;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 ；
• With a life expectancy of ≥12 weeks;
• Adequate bone marrow reserve and organ system functions;
• Women of Childbearing Potential (WOBCP) must undergo a serum pregnancy test within seven days before the first medication and the results are negative. WOBCP or men and their WOBCP partners should agree to take effective contraceptive measures from the signing of ICF until 180 days after the last dose of the study drug is used;
• Willing to provide written informed consent.