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

NCT03505996 | Completed Phase 2

• 2 other identifiers: CS1001-202CTR20180423
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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)

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

  From first patient first visit to 6 month after last patient first visit

Study Arms (1)

CS1001

EXPERIMENTAL

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

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CStone Pharmaceuticals: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

Location

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

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: April 15, 2018
• First Posted: April 23, 2018
• Study Start: May 22, 2018
• Primary Completion: February 19, 2020
• Study Completion: November 1, 2021
• Last Updated: October 31, 2022

Record last verified: 2022-10

Locations

CN (1)