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NCT Number: NCT06465446

A Study of IMM01 Plus 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).

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Key information

Conditions

Classic Hodgkin Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tislelizumab

Biological

IV infusion

IMM01

Biological

2.0mg/kg, IV infusion

Other names: Timdarpacept

Bendamustine

Drug

IV infusion

Gemcitabine

Drug

IV infusion

Primary outcomes

  1. 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.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: approximately 36 months

    OS is defined as the time from randomization to death due to any cause.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Jun 18, 2024
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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