A Study of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma

NCT ID: NCT03505996

Last Updated: 2022-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-22
• Study Completion Date: 2021-11-01

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CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn or death.The primary endpoint of this trial is objective response rate (ORR), as assessed by independent radiological review committee (IRRC) based on Criteria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.

Conditions

Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CS1001

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

Group Type: EXPERIMENTAL

CS1001

Intervention Type: BIOLOGICAL

Monoclonal antibody

Interventions

CS1001

Monoclonal antibody

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Subjects with histologically confirmed cHL at study site.

2. Relapsed or refractory cHL that failed at least two lines of systemic therapy.

3. ECOG PS of 0-2.

4. Subjects with at least one measurable lesion at baseline.

5. 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

6. Subjects who agree to use highly effective contraception.

Exclusion Criteria

1. Nodular lymphocyte predominant Hodgkin lymphoma or grey zone lymphoma.

2. Primary site in central nervous system (CNS) or CNS involvement.

3. Subjects currently participating in other clinical studies or use of any investigational drug within 4 weeks prior to the first dose of CS1001.

4. Subjects who had systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of CS1001.

5. Subject who had chemotherapy, immune therapy or biological therapy as systemic anti-cancer treatment within 28 days prior to the first dose of CS1001.

6. Receipt of traditional medicinal herbal preparations within 7 days prior to the first dose of CS1001.

7. Known history of human immunodefiency virus (HIV) infection and/or acquired immune deficiency syndrome.

8. Subjects with active Hepatitis B or C infection.

9. Subjects with active tuberculosis infection.

10. Subjects who received prior therapy with anti-PD-1, anti-PD-L1 or anti CTLA-4 monoclonal antibody.

11. Female subjects who are pregnant or breast-feeding.

For more information regarding trial participation, please contact at cstonera@cstonepharma.com

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CStone Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hospital

Beijing, , China

Countries

China

Other Identifiers

CTR20180423

Identifier Type: REGISTRY

Identifier Source: secondary_id

CS1001-202

Identifier Type: -

Identifier Source: org_study_id