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

NCT05189093 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-04-20

No results posted yet for this study

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 .

Conditions

  • Relapsed/Refractory Lymphoma

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).

Sponsors & Collaborators

  • Hangzhou Hanx Biopharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Yuankai Shi · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2025-06-25
Completion
2025-12-31

Countries

  • China

Study Locations

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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 NCT05189093 on ClinicalTrials.gov