Trials / Not Yet Recruiting
Not Yet RecruitingNCT06465446
A Study of IMM01 Plus Tiselizumab Versus Physician's Choice Chemotherapy in PD(L)1-refractory Classical Hodgkin Lymphoma
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
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 202 (estimated)
- Sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tislelizumab | IV infusion |
| BIOLOGICAL | IMM01 | 2.0mg/kg, IV infusion |
| DRUG | Bendamustine | IV infusion |
| DRUG | Gemcitabine | IV infusion |
Timeline
- Start date
- 2024-06-01
- Primary completion
- 2026-06-01
- Completion
- 2029-07-01
- First posted
- 2024-06-18
- Last updated
- 2024-06-24
Source: ClinicalTrials.gov record NCT06465446. Inclusion in this directory is not an endorsement.