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

Classic Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06465446
• Other study ID #: IMM01-008
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: July 2029

Study information

• Verified date: May 2024
• Source: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 202
• Est. completion date: July 2029
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Classic Hodgkin Lymphoma
• Hodgkin Disease
• Lymphoma

Intervention

Biological:
• Tislelizumab
IV infusion
• Timdarpacept
2.0mg/kg, IV infusion

Drug:
• Bendamustine
IV infusion
• Gemcitabine
IV infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS) per Lugano 2014 as Assessed by Independent Review Committee (IRC)		approximately 24 months
Secondary	Overall Survival (OS)		approximately 36 months
Secondary	Duration of Response (DOR)		approximately 24 months
Secondary	Number of Participants Who Experienced At Least One Adverse Event (AE)		approximately 18 months