About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Tislelizumab
- IMM01
- Bendamustine
- Gemcitabine