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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2029-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Classic Hodgkin Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type BIOLOGICAL

IV infusion

IMM01

Intervention Type BIOLOGICAL

2.0mg/kg, IV infusion

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.

Group Type ACTIVE_COMPARATOR

Bendamustine

Intervention Type DRUG

IV infusion

Gemcitabine

Intervention Type DRUG

IV infusion

Interventions

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Tislelizumab

IV infusion

Intervention Type BIOLOGICAL

IMM01

2.0mg/kg, IV infusion

Intervention Type BIOLOGICAL

Bendamustine

IV infusion

Intervention Type DRUG

Gemcitabine

IV infusion

Intervention Type DRUG

Other Intervention Names

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Timdarpacept

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No