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

NCT03595657 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CS1001-201CTR20180519
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 17

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)

Conditions

Extranodal Natural Killer/T-Cell Lymphoma

Keywords

ENKTL

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) Assessed by IRRC

  ORR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

  From enrollment to end of follow-up, a median of 29 months

Secondary Outcomes (10)

• Objective Response Rate (ORR) Assessed by Investigators

  From enrollment to end of follow-up, a median of 29 months

• Complete Response Rate (CRR) by Investigators

  From enrollment to end of follow-up, a median of 29 months

• Complete Response Rate (CRR) Assessed by IRRC

  From enrollment to end of follow-up, a median of 29 months

• Partial Response Rate (PRR) Assessed by Investigators

  From enrollment to end of follow-up, a median of 29 months

• Partial Response Rate (PRR) Assessed by IRRC

  From enrollment to end of follow-up, a median of 29 months

Other Outcomes (3)

• 6-months Progression-free Survival (PFS) Rate Assessed by Investigators

  6 months

• 6-months PFS Rate Assessed by IRRC

  6 months

• 6-month Overall Survival (OS) Rate

  6 months

Study Arms (1)

CS1001

EXPERIMENTAL

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

Biological: CS1001

Interventions

CS1001 BIOLOGICAL

monoclonal antibody

CS1001

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CStone Pharmaceuticals: lead

Study Sites (17)

Peking University Third Hospital

Beijing, China

Location

Hunan Cancer Hospital

Changsha, China

Location

West China Hospital of Sichuan University

Chengdu, China

Location

Fujian Cancer Hospital

Fuzhou, China

Location

Sun Yat-sen University Cancer Prevention Center

Guangzhou, China

Location

Guizhou Cancer Hospital

Guiyang, China

Location

The First Affiliated Hospital of Zhejiang University

Hangzhou, China

Location

Zhejiang Cancer Hospital

Hangzhou, China

Location

Anhui Cancer Hospital

Hefei, China

Location

Cancer Hospital Affiliated to Guangxi Medical University

Nanning, China

Location

Fudan University Shanghai Cancer Hospital

Shanghai, China

Location

Shanghai East Hospital

Shanghai, China

Location

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Liaoning Cancer Hospital

Shenyang, China

Location

Tianjin Cancer Hospital

Tianjin, China

Location

Cancer Center of Union Hospital, Huazhong University of Science and Technology

Wuhan, China

Location

Henan Cancer Hospital

Zhengzhou, China

Location

Related Publications (1)

• 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.

  PMID: 36996373 DERIVED

Results Point of Contact

• Title: Zhang Wenyun
• Organization: CStone Pharmaceuticals

CstoneRA@cstonepharma.com

+86 021-60333416

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 23, 2018
• Study Start: June 12, 2018
• Primary Completion: March 20, 2023
• Study Completion: March 20, 2023
• Last Updated: June 18, 2024
• Results First Posted: June 18, 2024

Record last verified: 2024-05

Locations

CN (17)