Back to resultsA Study of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma
Primary Purpose
Hodgkin Lymphoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CS1001
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Subjects with histologically confirmed cHL at study site.
- Relapsed or refractory cHL that failed at least two lines of systemic therapy.
- ECOG PS of 0-2.
- Subjects with at least one measurable lesion at baseline.
- Subjects treated by prior anti-cancer therapy whose toxicity resolved to baseline or =< Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
- Subjects who agree to use highly effective contraception.
Exclusion Criteria:
- Nodular lymphocyte predominant Hodgkin lymphoma or grey zone lymphoma.
- 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 had systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of CS1001.
- Subject who had chemotherapy, immune therapy or biological therapy as systemic anti-cancer treatment within 28 days prior to the first dose of CS1001.
- Receipt of traditional medicinal herbal preparations within 7 days prior to the first dose of CS1001.
- Known history of human immunodefiency 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
Sites / Locations
- Beijing Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CS1001
Arm Description
Participants will receive CS1001 1200 mg by intravenous infusion every three weeks
Outcomes
Primary Outcome Measures
Objective response rate (ORR)
The percentage of subjects whose best overall response is either complete response or partial response evaluated by IRRC according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Secondary Outcome Measures
Full Information
NCT ID
NCT03505996
First Posted
April 15, 2018
Last Updated
October 27, 2022
Sponsor
CStone Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT03505996
Brief Title
A Study of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma
Official Title
A Single-Arm, Multicenter, Phase II Clinical Trial of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 22, 2018 (Actual)
Primary Completion Date
February 19, 2020 (Actual)
Study Completion Date
November 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CStone Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multicenter, single-arm phase II study to evaluate the efficacy and safety of CS1001 monotherapy for relapsed/refractory classical Hodgkin Lymphoma (rr-cHL)
Detailed Description
Eligible subjects with rr-cHL who failed at least two prior lines of therapies are planned to receive CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn or 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CS1001
Arm Type
Experimental
Arm Description
Participants will receive CS1001 1200 mg by intravenous infusion every three weeks
Intervention Type
Biological
Intervention Name(s)
CS1001
Intervention Description
Monoclonal antibody
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
The percentage of subjects whose best overall response is either complete response or partial response evaluated by IRRC according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Time Frame
From first patient first visit to 6 month after last patient first visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with histologically confirmed cHL at study site.
Relapsed or refractory cHL that failed at least two lines of systemic therapy.
ECOG PS of 0-2.
Subjects with at least one measurable lesion at baseline.
Subjects treated by prior anti-cancer therapy whose toxicity resolved to baseline or =< Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Subjects who agree to use highly effective contraception.
Exclusion Criteria:
Nodular lymphocyte predominant Hodgkin lymphoma or grey zone lymphoma.
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 had systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of CS1001.
Subject who had chemotherapy, immune therapy or biological therapy as systemic anti-cancer treatment within 28 days prior to the first dose of CS1001.
Receipt of traditional medicinal herbal preparations within 7 days prior to the first dose of CS1001.
Known history of human immunodefiency 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
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma
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