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Recruiting Phase 1, Phase 2 NCT05189093

Recombinant Humanized Anti-CD47/PD-1 Bifunctional Antibody HX009 in Patients With Relapsed/Refractory Lymphoma

Trial Parameters

Condition Relapsed/Refractory Lymphoma
Sponsor Hangzhou Hanx Biopharmaceuticals, Ltd.
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 99
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2021-12-31
Completion 2025-12-31
Interventions
Recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection

Brief Summary

This study is a multi-center, open, single-arm phase I/II clinical study to evaluate the recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection in Chinese patients with relapsed/refractory lymphoma .

Eligibility Criteria

Inclusion criteria: 1. Voluntarily participating in a clinical research study, being fully aware of and informed about the study and signing the Informed Consent Form (ICF). Willing to follow and capable of completing all study procedures; 2. Male and Female. Age 18-65 years (including borderline values) in the dose-escalation phase; age 18-70 years (including borderline values) in the efficacy exploration and confirmation phase; 3. lymphoma diagnosed according to the 5th edition of the WHO Classification Criteria for 2022 and meeting the following definition of relapsed or refractory. * The Phase Ib efficacy exploration phase will carry out cohort expansion according to the following tumors: * Patients with relapsed/refractory diffuse large B-cell lymphoma (including transformed DLBCL): need to have received systemic therapy with at least two standard regimens; * Relapsed/refractory peripheral T-cell lymphoma (except angioimmunoblastic T-cell lymphoma): Patients with relapsed/refracto

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