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).
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).
Parallel
Tislelizumab
Biological/VaccineIV infusion
IMM01
Biological/Vaccine2.0mg/kg, IV infusion
Bendamustine
DrugIV infusion
Gemcitabine
DrugIV infusion
Progression Free Survival (PFS) per Lugano 2014 as Assessed by Independent Review Committee (IRC)
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Duration of Response (DOR)
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.
Number of Participants Who Experienced At Least One Adverse Event (AE)
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.
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