drugset / Trial / NCT06465446
A Study of IMM01 Plus Tiselizumab Versus Physician's Choice Chemotherapy in PD(L)1-refractory Classical Hodgkin Lymphoma
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2024-06
- Primary completion
- 2026-06
- Completion
- 2029-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bendamustine | Small molecule | — | Intravenous |
| Comparator | Gemcitabine | Small molecule | 90 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 120 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | IMM01 | Protein / enzyme biologic | 2 mg/kg | Intravenous |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |