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

A Single-Arm, Multicenter, Phase II Clinical Trial of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma

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)

Study Overview

• Status: Completed
• Conditions: Hodgkin Lymphoma
• Intervention / Treatment: Biological: CS1001

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CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn or death.The primary endpoint of this trial is objective response rate (ORR), as assessed by independent radiological review committee (IRRC) based on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

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

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

Description

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

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 three weeks	Biological: CS1001; Monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CStone Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2018
• Primary Completion (Actual): February 19, 2020
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: April 15, 2018
• First Submitted That Met QC Criteria: April 15, 2018
• First Posted (Actual): April 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease
• Other Study ID Numbers: CS1001-202; CTR20180423 (Registry Identifier: www.chinadrugtrials.org.cn)

Drug and device information, study documents

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