A Study of IMM01 Plus Tiselizumab Versus Physician's Choice Chemotherapy in PD(L)1-refractory Classical Hodgkin Lymphoma

June 19, 2024 updated by: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

A Phase III Randomized, Open-label, Multicenter Clinical Study of IMM01 (Timdarpacept) in Combiniation With Tiselizumab Versus Physician's Choice Chemotherapy in PD-(L)1-refractory Classical Hodgkin Lymphoma

The purpose of this study is to compare efficacy of IMM01 plus Tiselizumab with physician's choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of IMM01 plus Tiselizumab. The primary study hypotheses are that IMM01 plus Tiselizuma is superior to physician's choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

202

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL).
  • PD (L)-1 refractory cHL and exhausted all available treatment options with known clinical benefit.
  • Has adequate bone marrow reserves and organ functions.

Exclusion Criteria:

  • History of central nervous system (CNS) metastases or active CNS involvement.
  • Received prior systemic anticancer therapy within 4 weeks before randomization.
  • Received prior ani-CD47 or SIRPa treatment.
  • History of human immunodeficiency virus (HIV).
  • Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
  • History of severve allergic reactions to any components of trail durg, humanized antibodies or fusion proteins.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMM01 plus Tiselizuma
Participants will receive IMM01 (2.0mg/kg) intravenously each week and tislelizumab (200mg) once every 3 weeks in 3-week treatment cycle, for up to 2 years.
Biological: Tislelizumab
IV infusion
Biological: IMM01
2.0mg/kg, IV infusion
Other Names:
  • Timdarpacept
Active Comparator: Physician's Choice Chemotherapy

Participants will receive physician's choice of either bendamustine or gemcitabie.

Gemciabine: 90 or 120 mg/m^2 on Day 1 and Day 2, IV, 4-week cycle, for up to 6 cycles.

Gemcitabine: 1000 mg/m^2 on Day 1 and Day 8, IV, 3-week cycle, for up to 6 cycles.
Drug: Gemcitabine
IV infusion
Drug: Bendamustine
IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) per Lugano 2014 as Assessed by Independent Review Committee (IRC)
Time Frame: approximately 24 months
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
approximately 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: approximately 36 months
OS is defined as the time from randomization to death due to any cause.
approximately 36 months
Duration of Response (DOR)
Time Frame: approximately 24 months
DOR is defined as the time from the first documented evidence of complete response or partial response until disease progression or death due to any cause, whichever occurs first.
approximately 24 months
Number of Participants Who Experienced At Least One Adverse Event (AE)
Time Frame: approximately 18 months
An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.
approximately 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 19, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMM01-008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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