A Study of IMM01 Plus Tiselizumab Versus Physician's Choice Chemotherapy in PD(L)1-refractory Classical Hodgkin Lymphoma
- Conditions
- Classic Hodgkin Lymphoma
- Interventions
- Registration Number
- NCT06465446
- Lead Sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 202
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IMM01 plus Tiselizuma Tislelizumab 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. IMM01 plus Tiselizuma IMM01 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. Physician's Choice Chemotherapy Bendamustine 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. Physician's Choice Chemotherapy Gemcitabine 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.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) per Lugano 2014 as Assessed by Independent Review Committee (IRC) 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 Outcome Measures
Name Time Method Overall Survival (OS) approximately 36 months OS is defined as the time from randomization to death due to any cause.
Number of Participants Who Experienced At Least One Adverse Event (AE) 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.
Duration of Response (DOR) 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.