A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)
NCT ID: NCT03595657
Last Updated: 2024-06-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2018-06-12
2023-03-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CS1001
Participants will receive CS1001 1200 mg by intravenous infusion every 3 weeks
CS1001
monoclonal antibody
Interventions
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CS1001
monoclonal antibody
Eligibility Criteria
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Inclusion Criteria
2. Subject must have relapsed or refractory NKTL after prior asparaginase-based chemotherapy or chemo radiotherapy.
3. Eastern Cooperative Oncology Group Performance Status (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
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 [email protected]
18 Years
75 Years
ALL
No
Sponsors
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CStone Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
The First Affiliated Hospital of Zhejiang University
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Anhui Cancer Hospital
Hefei, , China
Cancer Hospital Affiliated to Guangxi Medical University
Nanning, , China
Fudan University Shanghai Cancer Hospital
Shanghai, , China
Shanghai East Hospital
Shanghai, , China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Liaoning Cancer Hospital
Shenyang, , China
Tianjin Cancer Hospital
Tianjin, , China
Cancer Center of Union Hospital, Huazhong University of Science and Technology
Wuhan, , China
Henan Cancer Hospital
Zhengzhou, , China
Countries
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References
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Huang H, Tao R, Hao S, Yang Y, Cen H, Zhou H, Guo Y, Zou L, Cao J, Huang Y, Jin J, Zhang L, Yang H, Xing X, Zhang H, Liu Y, Ding K, Qi Q, Zhu X, Zhu D, Wang S, Fang T, Dai H, Shi Q, Yang J. Sugemalimab Monotherapy for Patients With Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (GEMSTONE-201): Results From a Single-Arm, Multicenter, Phase II Study. J Clin Oncol. 2023 Jun 1;41(16):3032-3041. doi: 10.1200/JCO.22.02367. Epub 2023 Mar 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CTR20180519
Identifier Type: OTHER
Identifier Source: secondary_id
CS1001-201
Identifier Type: -
Identifier Source: org_study_id
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