Classic Hodgkin Lymphoma
Conditions
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).
Interventions
BIOLOGICALTislelizumab
IV infusion
BIOLOGICALIMM01
2.0mg/kg, IV infusion
DRUGBendamustine
IV infusion
DRUGGemcitabine
IV infusion
Sponsors
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) per Lugano 2014 as Assessed by Independent Review Committee (IRC) | approximately 24 months | PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | approximately 36 months | OS is defined as the time from randomization to death due to any cause. |
| Duration of Response (DOR) | approximately 24 months | DOR is defined as the time from the first documented evidence of complete response or partial response until disease progression or death due to any cause, whichever occurs first. |
| Number of Participants Who Experienced At Least One Adverse Event (AE) | approximately 18 months | An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Outcome results
None listed