NCT06793956 Sintilimab and Linperlisib Combination Treatment in Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma
| NCT ID | NCT06793956 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sun Yat-sen University |
| Condition | Extranodal Natural Killer/T Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-02-21 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2025-02-21 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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 malignancies within the past 5 years or concurrent malignancies (excluding basal cell carcinoma of the skin). 5. Patients with aggressive NK-cell leukemia or central nervous system involvement. 6. 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. 7. 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. 8. Patients with a history of interstitial lung disease (except for asymptomatic interstitial lung disease caused by radiotherapy).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06793956 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Extranodal Natural Killer/T Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06793956 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06793956 currently recruiting?
Yes, NCT06793956 is actively recruiting participants. Contact the research team at caiqq@sysucc.org.cn for enrollment information.
Where is the NCT06793956 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06793956 clinical trial?
NCT06793956 is sponsored by Sun Yat-sen University. The trial plans to enroll 12 participants.