A Study of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma
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ClinicalTrials.gov Identifier: NCT03505996 |
Recruitment Status :
Active, not recruiting
First Posted : April 23, 2018
Last Update Posted : February 17, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hodgkin Lymphoma | Biological: CS1001 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 82 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Single-Arm, Multicenter, Phase II Clinical Trial of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma |
Actual Study Start Date : | June 1, 2018 |
Actual Primary Completion Date : | February 19, 2020 |
Estimated Study Completion Date : | March 31, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: CS1001
Participants will receive CS1001 1200 mg by intravenous infusion every three weeks
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Biological: CS1001
Monoclonal antibody |
- Objective response rate (ORR) [ Time Frame: From first patient first visit to 6 month after last patient first visit ]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

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505996
China | |
Beijing Cancer Hospital | |
Beijing, China |
Responsible Party: | CStone Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03505996 |
Other Study ID Numbers: |
CS1001-202 CTR20180423 ( Registry Identifier: www.chinadrugtrials.org.cn ) |
First Posted: | April 23, 2018 Key Record Dates |
Last Update Posted: | February 17, 2022 |
Last Verified: | February 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |