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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03595657
Recruitment Status : Completed
First Posted : July 23, 2018
Last Update Posted : June 8, 2023
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Extranodal Natural Killer/T-Cell Lymphoma Biological: CS1001 Phase 2

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CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn, death.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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 12, 2018
Actual Primary Completion Date : March 20, 2023
Actual Study Completion Date : March 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: CS1001
Participants will receive CS1001 1200 mg by intravenous infusion every 3 weeks
Biological: CS1001
monoclonal antibody

Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: from first patient first visit to 6 months after last patient first visit ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject must have a histologically confirmed NKTL at study site.
  2. Subject must have relapsed or refractory NKTL after prior asparaginase-based chemotherapy or chemo radiotherapy.
  3. ECOG PS of 0 or 1.
  4. Subject must have at least one evaluable or measurable lesion per Lugano 2014 classification.
  5. Subject must have adequate organ function and bone marrow function without severe hematopoietic disorder, or heart, lung, liver or kidney dysfunction or immune deficiency.
  6. Subject must provide stained tumor tissue sections and corresponding pathological report or unstained tumor tissue sections (or tissue block) for central pathology review.
  7. 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:

  1. Invasive natural killer leukemia.
  2. Concomitant with hemophagocytic syndrome.
  3. Primary site in central nervous system (CNS) or CNS involvement.
  4. Subjects currently participating in other clinical studies or use of any investigational drug within 4 weeks prior to the first dose of CS1001.
  5. Subjects who received systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of CS1001.
  6. Subjects who had prior chemotherapy, immune therapy, biological therapy as systemic treatment for cancer, within 28 days prior to the first dose of CS1001.
  7. Receipt of traditional medicinal herbal preparations with anti-tumor indications with 7 days prior to the first dose of CS1001.
  8. Known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome.
  9. Subjects with active hepatitis B or C infection.
  10. Subjects with active tuberculosis infection.
  11. Subjects who received prior therapy with anti-PD-1, anti-PD-L1 or anti-CTLA-4 monoclonal antibody.
  12. Female subjects who are pregnant or breast-feeding.

For more information regarding trial participation, please contact at

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03595657

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United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
China, Guangdong
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
CStone Pharmaceuticals
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Responsible Party: CStone Pharmaceuticals Identifier: NCT03595657    
Other Study ID Numbers: CS1001-201
CTR20180519 ( Other Identifier: )
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: June 8, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CStone Pharmaceuticals:
Additional relevant MeSH terms:
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Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin