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

NCT06465446 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2024-06-24

No results posted yet for this study

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).

Conditions

  • Classic Hodgkin Lymphoma

Interventions

BIOLOGICAL

Tislelizumab

IV infusion

BIOLOGICAL

IMM01

2.0mg/kg, IV infusion

DRUG

Bendamustine

IV infusion

DRUG

Gemcitabine

IV infusion

Sponsors & Collaborators

  • ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2026-06-30
Completion
2029-07-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06465446 on ClinicalTrials.gov