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

ImmuneOnco Biopharmaceuticals

Status and phase: Not yet enrolling; Phase 3

Conditions: Classic Hodgkin Lymphoma

Treatments: Biological: Tislelizumab; Drug: Bendamustine; Drug: Gemcitabine; Biological: IMM01

Study type: Interventional

Funder types: Other

Identifiers

NCT06465446

IMM01-008

Details and patient eligibility

About

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).

Enrollment: 202 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 2 patient groups

IMM01 plus Tiselizuma

Experimental group

Description:

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.

Treatment:

Biological: IMM01

Biological: Tislelizumab

Physician's Choice Chemotherapy

Active Comparator group

Description:

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.

Treatment:

Drug: Gemcitabine

Drug: Bendamustine