Back to resultsA Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)
Primary Purpose
Extranodal Natural Killer/T-Cell Lymphoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CS1001
Sponsored by
About this trial
This is an interventional treatment trial for Extranodal Natural Killer/T-Cell Lymphoma focused on measuring ENKTL
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
Sites / Locations
- The University of Texas MD Anderson Cancer Center
- Sun Yat-Sen University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CS1001
Arm Description
Participants will receive CS1001 1200 mg by intravenous infusion every 3 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03595657
Brief Title
A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 12, 2018 (Actual)
Primary Completion Date
March 20, 2023 (Actual)
Study Completion Date
March 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CStone Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extranodal Natural Killer/T-Cell Lymphoma
Keywords
ENKTL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CS1001
Arm Type
Experimental
Arm Description
Participants will receive CS1001 1200 mg by intravenous infusion every 3 weeks
Intervention Type
Biological
Intervention Name(s)
CS1001
Intervention Description
monoclonal antibody
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
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.
Time Frame
from first patient first visit to 6 months after last patient first visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)
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