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

IMM01-008

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).

2024-06-01

2026-06-01

2029-07-01

Not yet recruiting

Early phase I

202

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 202, 'type': 'ESTIMATED'}}

2024-06-18