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A Study of IMM01 Plus Tiselizumab Versus Physician's Choice Chemotherapy in PD(L)1-refractory Classical Hodgkin Lymphoma

StatusNot Yet Recruiting
PhasePhase 3
Started2024-06
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 24, 2024 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2024-06-19
Study Identification, Study Status, Arms and Interventions, Outcome Measures v1
InterventionsBendamustine (Drug), Gemcitabine (Drug), Timdarpacept (Biological), Tislelizumab (Biological)→Bendamustine (Drug), Gemcitabine (Drug), IMM01 (Biological), Tislelizumab (Biological)
Secondary endpointsdetails revised at 3 of 3 entries
Study title-17 characters
A Study of IMM01 in Combiniation WithPlus Tiselizumab Versus Physician's Choice Chemotherapy in PD-(L)1-refractory Classical Hodgkin Lymphoma
2024-06-13
Original filing
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).
Trial Details
NCT Number NCT06465446
Lead Sponsor ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Conditions Classic Hodgkin Lymphoma
Enrollment 202 participants
Start Date 2024-06
Primary Completion 2026-06 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2024-06-24