Clinical trial · Interventional
A Study of IMM01 Plus Tiselizumab Versus Physician's Choice Chemotherapy in PD(L)1-refractory Classical Hodgkin Lymphoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Classic Hodgkin Lymphoma | Classic Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| IMM01 | Biological | — | UNRESOLVED |
| Tislelizumab | Biological | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IMM01 plus Tiselizuma
- 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.
- interventionNames
- Biological: Tislelizumab
- Biological: IMM01
- type
- ACTIVE_COMPARATOR
- label
- Physician's Choice Chemotherapy
- 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.
- interventionNames
- Drug: Bendamustine
- Drug: Gemcitabine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available