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Trial Title:
A Study of IMM01 Plus Tiselizumab Versus Physician's Choice Chemotherapy in PD(L)1-refractory Classical Hodgkin Lymphoma
NCT ID:
NCT06465446
Condition:
Classic Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Hodgkin Disease
Gemcitabine
Tislelizumab
Bendamustine Hydrochloride
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Tislelizumab
Description:
IV infusion
Arm group label:
IMM01 plus Tiselizuma
Intervention type:
Biological
Intervention name:
IMM01
Description:
2.0mg/kg, IV infusion
Arm group label:
IMM01 plus Tiselizuma
Other name:
Timdarpacept
Intervention type:
Drug
Intervention name:
Bendamustine
Description:
IV infusion
Arm group label:
Physician's Choice Chemotherapy
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
IV infusion
Arm group label:
Physician's Choice Chemotherapy
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).
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
June 2024
Completion date:
July 2029
Lead sponsor:
Agency:
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Agency class:
Other
Source:
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06465446
