Sintilimab and Linperlisib Combination Treatment in Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma

Key Inclusion Criteria:

• Pathologically confirmed extranodal NKTCL.
• Voluntary participation in the clinical study; fully understand the study, and have signed the written informed consent form.
• Age ≥ 18 years.
• Relapsed or refractory NKTCL after failure of at least one line of asparaginase-based chemotherapy or chemoradiotherapy regimen.
• ECOG performance status: 0-2.
• Estimated survival time ≥ 3 months.
• At least one measurable lesion according to the Lugano 2014 lymphoma evaluation criteria.
• Adequate organ and bone marrow function.

Key Exclusion Criteria:

• Patients previously treated with PI3K inhibitors.
• Patients with hemophagocytic syndrome.
• Patients known to be allergic to any component of monoclonal antibodies.
• Patients with a history of other malignancies within the past 5 years or concurrent malignancies (excluding basal cell carcinoma of the skin).
• Patients with aggressive NK-cell leukemia or central nervous system involvement.
• Patients who have participated in other drug clinical trials within 4 weeks prior to the start of this study or have received anti-tumor treatment within 4 weeks before the study initiation.
• Patients with clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction) or patients who have undergone total gastrectomy.
• Patients with a history of interstitial lung disease (except for asymptomatic interstitial lung disease caused by radiotherapy).