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

Phase 2

Completed

Conditions: Extranodal Natural Killer/T-Cell Lymphoma

Interventions: Biological: CS1001

Registration Number: NCT03595657

Lead Sponsor: CStone Pharmaceuticals

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CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn, death.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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

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.
Eastern Cooperative Oncology Group Performance Status (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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CS1001	CS1001	Participants will receive CS1001 1200 mg by intravenous infusion every 3 weeks

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) Assessed by IRRC	From enrollment to end of follow-up, a median of 29 months	ORR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Secondary Outcome Measures

Name	Time	Method
Time to Response (TTR) Assessed by IRRC	From enrollment to end of follow-up, a median of 29 months	TTR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Complete Response Rate (CRR) Assessed by IRRC	From enrollment to end of follow-up, a median of 29 months	CRR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Duration of Response (DoR) Assessed by Investigators	From enrollment to end of follow-up, a median of 29 months	DoR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Objective Response Rate (ORR) Assessed by Investigators	From enrollment to end of follow-up, a median of 29 months	ORR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Partial Response Rate (PRR) Assessed by Investigators	From enrollment to end of follow-up, a median of 29 months	PRR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Partial Response Rate (PRR) Assessed by IRRC	From enrollment to end of follow-up, a median of 29 months	PRR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Complete Response Rate (CRR) by Investigators	From enrollment to end of follow-up, a median of 29 months	CRR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Time to Response (TTR) Assessed by Investigators	From enrollment to end of follow-up, a median of 29 months	TTR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Duration of Response (DoR) Assessed by IRRC	From enrollment to end of follow-up, a median of 29 months	DoR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Number of Participants With Adverse Events	From enrollment to end of follow-up, a median of 29 months

Trial Locations

Locations (17): Zhejiang Cancer Hospital
🇨🇳
Hangzhou, China
Shanghai East Hospital
🇨🇳
Shanghai, China
Peking University Third Hospital
🇨🇳
Beijing, China
Hunan Cancer Hospital
🇨🇳
Changsha, China
West China Hospital of Sichuan University
🇨🇳
Chengdu, China
Fujian Cancer Hospital
🇨🇳
Fuzhou, China
Sun Yat-sen University Cancer Prevention Center
🇨🇳
Guangzhou, China
Guizhou Cancer Hospital
🇨🇳
Guiyang, China
Anhui Cancer Hospital
🇨🇳
Hefei, China
The First Affiliated Hospital of Zhejiang University
🇨🇳
Hangzhou, China
Liaoning Cancer Hospital
🇨🇳
Shenyang, China
Cancer Hospital Affiliated to Guangxi Medical University
🇨🇳
Nanning, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳
Shanghai, China
Henan Cancer Hospital
🇨🇳
Zhengzhou, China
Fudan University Shanghai Cancer Hospital
🇨🇳
Shanghai, China
Tianjin Cancer Hospital
🇨🇳
Tianjin, China
Cancer Center of Union Hospital, Huazhong University of Science and Technology
🇨🇳
Wuhan, China