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

A Single-Arm, Multicenter, Phase II Clinical Trial of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)

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)

Study Overview

• Status: Completed
• Conditions: Extranodal Natural Killer/T-Cell Lymphoma
• Intervention / Treatment: Biological: CS1001

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CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn, death.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
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University Third Hospital
  • Changsha, China
    • Hunan Cancer Hospital
  • Chengdu, China
    • West China Hospital of Sichuan University
  • Fuzhou, China
    • Fujian Cancer Hospital
  • Guangzhou, China
    • Sun Yat-sen University Cancer prevention Center
  • Guiyang, China
    • Guizhou Cancer Hospital
  • Hangzhou, China
    • The First Affiliated Hospital of Zhejiang University
  • Hangzhou, China
    • Zhejiang Cancer Hospital
  • Hefei, China
    • Anhui Cancer Hospital
  • Nanning, China
    • Cancer Hospital Affiliated to Guangxi Medical University
  • Shanghai, China
    • Fudan University Shanghai Cancer Hospital
  • Shanghai, China
    • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Shanghai, China
    • Shanghai East Hospital
  • Shenyang, China
    • Liaoning Cancer Hospital
  • Tianjin, China
    • Tianjin cancer hospital
  • Wuhan, China
    • Cancer Center of Union Hospital, Huazhong University of Science and Technology
  • Zhengzhou, China
    • Henan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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. 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) Assessed by Investigators	ORR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification	From enrollment to end of follow-up, a median of 29 months
Complete Response Rate (CRR) by Investigators	CRR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification	From enrollment to end of follow-up, a median of 29 months
Complete Response Rate (CRR) Assessed by IRRC	CRR 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
Partial Response Rate (PRR) Assessed by Investigators	PRR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification	From enrollment to end of follow-up, a median of 29 months
Partial Response Rate (PRR) Assessed by IRRC	PRR 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
Duration of Response (DoR) Assessed by Investigators	DoR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification	From enrollment to end of follow-up, a median of 29 months
Duration of Response (DoR) Assessed by IRRC	DoR 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
Time to Response (TTR) Assessed by Investigators	TTR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification	From enrollment to end of follow-up, a median of 29 months
Time to Response (TTR) Assessed by IRRC	TTR 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
Number of Participants With Adverse Events		From enrollment to end of follow-up, a median of 29 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-months Progression-free Survival (PFS) Rate Assessed by Investigators	6-months PFS rate assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification	6 months
6-months PFS Rate Assessed by IRRC	6-months PFS rate assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification	6 months
6-month Overall Survival (OS) Rate		6 months

Collaborators and Investigators

• Sponsor: CStone Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2018
• Primary Completion (Actual): March 20, 2023
• Study Completion (Actual): March 20, 2023

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: ENKTL
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: CS1001-201; CTR20180519 (Other Identifier: www.chinadrugtrials.org.cn)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No