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

NCT06465446 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: IMM01-008
• Study Type: interventional
• Target: 202
• Locations: 0 countries
• Sites: N/A

Brief 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

Classic Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) per Lugano 2014 as Assessed by Independent Review Committee (IRC)

  PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.

  approximately 24 months

Secondary Outcomes (3)

• Overall Survival (OS)

  approximately 36 months

• Duration of Response (DOR)

  approximately 24 months

• Number of Participants Who Experienced At Least One Adverse Event (AE)

  approximately 18 months

Study Arms (2)

IMM01 plus Tiselizuma

EXPERIMENTAL

Participants will receive IMM01 (2.0mg/kg) intravenously each week and tislelizumab (200mg) once every 3 weeks in 3-week treatment cycle, for up to 2 years.

Biological: Tislelizumab; Biological: IMM01

Physician's Choice Chemotherapy

ACTIVE COMPARATOR

Participants will receive physician's choice of either bendamustine or gemcitabie. Gemciabine: 90 or 120 mg/m\^2 on Day 1 and Day 2, IV, 4-week cycle, for up to 6 cycles. Gemcitabine: 1000 mg/m\^2 on Day 1 and Day 8, IV, 3-week cycle, for up to 6 cycles.

Drug: Bendamustine; Drug: Gemcitabine

Interventions

Tislelizumab BIOLOGICAL

IV infusion

IMM01 plus Tiselizuma

IMM01 BIOLOGICAL

2.0mg/kg, IV infusion

Also known as: Timdarpacept

IMM01 plus Tiselizuma

Bendamustine DRUG

IV infusion

Physician's Choice Chemotherapy

Gemcitabine DRUG

IV infusion

Physician's Choice Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ImmuneOnco Biopharmaceuticals (Shanghai) Inc.: lead

MeSH Terms

Interventions

tislelizumab; Bendamustine Hydrochloride; Gemcitabine

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 24, 2024

Record last verified: 2024-06