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

• ClinicalTrials.gov Identifier: NCT03595657
• Recruitment Status: Completed
• First Posted: July 23, 2018
• Last Update Posted: June 8, 2023
• Sponsor: CStone Pharmaceuticals
• Information provided by (Responsible Party): CStone Pharmaceuticals

Tracking Information

• First Submitted Date: July 12, 2018
• First Posted Date: July 23, 2018
• Last Update Posted Date: June 8, 2023
• Actual Study Start Date: June 12, 2018
• Actual Primary Completion Date: March 20, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 12, 2018)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn, death.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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Extranodal Natural Killer/T-Cell Lymphoma

Intervention

Biological: CS1001

monoclonal antibody

Study Arms

Experimental: CS1001

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

Intervention: Biological: CS1001

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 12, 2018): 80
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 20, 2023
• Actual Primary Completion Date: March 20, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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 cstonera@cstonepharma.com

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China, United States
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT03595657
• Other Study ID Numbers: CS1001-201; CTR20180519 ( Other Identifier: www.chinadrugtrials.org.cn )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: CStone Pharmaceuticals
• Original Responsible Party: Same as current
• Current Study Sponsor: CStone Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: CStone Pharmaceuticals
• Verification Date: June 2023