Sintilimab and Linperlisib Combination Treatment in Relapsed or Refractory Extranodal Natu
This is an open-label, phase Ib study evaluating the combination treatment of sintilimab and linperlisib in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (NKTCL).
| Condition(s) | Extranodal Natural Killer/T Cell Lymphoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This is an open-label, phase Ib study evaluating the combination treatment of sintilimab and linperlisib in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (NKTCL). |
| Who can participate | Key Inclusion Criteria: 1. Pathologically confirmed extranodal NKTCL. 2. Voluntary participation in the clinical study; fully understand the study, and have signed the written informed consent form. 3. Age ≥ 18 years. 4. Relapsed or refractory NKTCL after failure of at least one line of asparaginase-based chemotherapy or chemoradiotherapy regimen. 5. ECOG performance status: 0-2. 6. Estimated survival time ≥ 3 months. 7. At least one measurable lesion according to the Lugano 2014 lymphoma evaluation criteria. 8. Adequate organ and bone marrow function. Key Exclusion Criteria: 1. Patients previously treated with PI3K inhibitors. 2. Patients with hemophagocytic syndrome. 3. Patients known to be allergic to any component of monoclonal antibodies. 4. Patients with a history of other malignanci |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Sun Yat-sen University |
| Locations | Guangzhou, Guangdong, China |
| Start date | 2025-02-21 |
| NCT ID | NCT06793956 |
| Official listing | https://clinicaltrials.gov/study/NCT06793956 |