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

Open-Label, Phase Ib Study of Sintilimab and Linperlisib Combination Treatment in Patients with Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma (NKTCL)

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).

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Qingqing Cai, MD. PhD.; Phone Number: 0086-20-87342823; Email: caiqq@sysucc.org.cn

Study Locations

• China
  • Guang Dong
    • Guang Zhou, Guang Dong, China, 51000
      • Recruiting
      • Sun Yat-sen Universitiy Cancer Center
      • Contact: Qingqing Cai; Phone Number: 0086-20-87342823; Email: caiqq@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sintilimab and Linperlisib Combination Treatment	Drug: Sintilimab and Linperlisib Combination Treatment; Sintilimab administered via intravenous infusion; Linperlisib administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLT	Dose-limiting toxicity	Cycle 1 (21 days)
RP2D	Phase II Recommended Dose	Cycle 1 (21 days)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2025
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 31, 2030

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Sintilimab; Linperlisib; Extranodal Natural Killer/T Cell Lymphoma
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: B2024-753

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No