A Study of IMM01 Plus Tiselizumab Versus Physician's Choice Chemotherapy in PD(L)1-refractory Classical Hodgkin Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tislelizumab, IMM01, Bendamustine, Gemcitabine.
- Who it may be relevant to
- Registry conditions: Classic Hodgkin Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
Interventions
- Biological Tislelizumab
IV infusion - Biological IMM01
2.0mg/kg, IV infusion - Drug Bendamustine
IV infusion - Drug Gemcitabine
IV infusion
Primary outcome measures
- Progression Free Survival (PFS) per Lugano 2014 as Assessed by Independent Review Committee (IRC) [Time frame: approximately 24 months]
Secondary outcome measures (3)
- Overall Survival (OS) [Time frame: approximately 36 months]
- Duration of Response (DOR) [Time frame: approximately 24 months]
- Number of Participants Who Experienced At Least One Adverse Event (AE) [Time frame: approximately 18 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06465446 · IMM01-008