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NOT YET RECRUITING
NCT06465446
PHASE3

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

Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

202

Start Date

2024-06

Completion Date

2029-07

Last Updated

2024-06-24

Healthy Volunteers

No

Interventions

BIOLOGICAL

Tislelizumab

IV infusion

BIOLOGICAL

IMM01

2.0mg/kg, IV infusion

DRUG

Bendamustine

IV infusion

DRUG

Gemcitabine

IV infusion