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RECRUITING
NCT05189093
PHASE1/PHASE2

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

Sponsor: Hangzhou Hanx Biopharmaceuticals, Ltd.

View on ClinicalTrials.gov

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 .

Official title: To Evaluate the Multi-center, Open, Single-arm Phase I/II Clinical Study of Recombinant Humanized Anti-CD47/PD-1 Bifunctional Antibody HX009 Injection in Chinese Patients With Relapsed/Refractory Lymphoma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

99

Start Date

2021-12-31

Completion Date

2026-12-31

Last Updated

2025-10-01

Healthy Volunteers

No

Interventions

DRUG

Recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection

There will be a total of 4 cohorts, each cohort will explore 1-2 dose levels, i.e. 10 mg/kg and 15 mg/kg, with an expected enrollment of 40-80 cases. The 10 mg/kg dose level will be enrolled first, the After discussion between the sponsor and the DSC, the 15 mg/kg dose level will be enrolled if necessary. Based on the DMC analysis, the no-trend cohort will be enrolled in a maximum of 10 cases (with the possibility of stopping enrollment halfway through).

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciense

Beijing, Beijing Municipality, China