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

Phase 1

Recruiting

• Conditions: Extranodal Natural Killer/T Cell Lymphoma
• Interventions: Drug: Sintilimab and Linperlisib Combination Treatment

• Registration Number: NCT06793956
• Lead Sponsor: Sun Yat-sen University

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-21
• Study First Posted: 2025-01-27
• Study Start: 2025-02-21
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2026-01-31
• Study Completion: 2030-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sintilimab and Linperlisib Combination Treatment	Sintilimab and Linperlisib Combination Treatment	-

Primary Outcome Measures

Name	Time	Method
DLT	Cycle 1 (21 days)	Dose-limiting toxicity
RP2D	Cycle 1 (21 days)	Phase II Recommended Dose

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Up to 24 weeks	To investigate the antitumor efficacy
AE and SAE	Up to 24 weeks	Number of participants with adverse events (AE) and severe adverse events (SAE)
2-year Progression-free survival(PFS)	Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment	To investigate the antitumor efficacy
2-year Overall survival(OS)	Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment	To investigate the antitumor efficacy

Trial Locations

Locations (1)

Sun Yat-sen Universitiy Cancer Center; 🇨🇳 Guang Zhou, Guang Dong, China