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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmuneOnco Biopharmaceuticals (Shanghai) Inc.

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Tislelizumab
  • IMM01
  • Bendamustine
  • Gemcitabine

Treatment groups

202 Participants
are divided into 2 treatment groups

Locations

This trial has no locations