A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, single-arm, phase II study to evaluate the efficacy and safety of CS1001 monotherapy for Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma (ENKTL)

Detailed Description
-----------------
Eligible subjects with rr-NKTL after prior asparaginase-based chemotherapy or chemo radiotherapy are planned to receive CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn, death. The primary endpoint of this trial is objective response rate (ORR), as assessed by independent radiological review committee (IRRC) based on Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification.

Official Title
-----------------
A Single-Arm, Multicenter, Phase II Clinical Trial of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)

Conditions
-----------------
Extranodal Natural Killer/T-Cell Lymphoma

Intervention / Treatment
-----------------
* Biological: CS1001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must have a histologically confirmed NKTL at study site. Subject must have relapsed or refractory NKTL after prior asparaginase-based chemotherapy or chemo radiotherapy. ECOG PS of 0 or 1. Subject must have at least one evaluable or measurable lesion per Lugano 2014 classification. Subject must have adequate organ function and bone marrow function without severe hematopoietic disorder, or heart, lung, liver or kidney dysfunction or immune deficiency. Subject must provide stained tumor tissue sections and corresponding pathological report or unstained tumor tissue sections (or tissue block) for central pathology review. Subject with prior anti-cancer treatment can only be enrolled when the toxicity of prior anti-cancer treatment has recovered to baseline or ≤ Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Exclusion Criteria: Invasive natural killer leukemia. Concomitant with hemophagocytic syndrome. Primary site in central nervous system (CNS) or CNS involvement. Subjects currently participating in other clinical studies or use of any investigational drug within 4 weeks prior to the first dose of CS1001. Subjects who received systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of CS1001. Subjects who had prior chemotherapy, immune therapy, biological therapy as systemic treatment for cancer, within 28 days prior to the first dose of CS1001. Receipt of traditional medicinal herbal preparations with anti-tumor indications with 7 days prior to the first dose of CS1001. Known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome. Subjects with active hepatitis B or C infection. Subjects with active tuberculosis infection. Subjects who received prior therapy with anti-PD-1, anti-PD-L1 or anti-CTLA-4 monoclonal antibody. Female subjects who are pregnant or breast-feeding. For more information regarding trial participation, please contact at cstonera@cstonepharma.com

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CS1001<br>Participants will receive CS1001 1200 mg by intravenous infusion every 3 weeks | Biological: CS1001<br>* monoclonal antibody<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | The primary efficacy endpoint is ORR assessed by IRRC, defined as proportion of subjects who achieve complete response or partial response as the best response in all subjects with evaluable or measurable lesions. | from first patient first visit to 6 months after last patient first visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ENKTL