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

Relapsed/Refractory Lymphoma Clinical Trial

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

Status Recruiting

Clinical Trial 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 .

Clinical Trial Description

The study is comprised of two parts: phase I is the dose escalation part, and phase II is the efficacy exploratory part and the efficacy confirmation part.

Phase I dose escalation part: it is planned to recruit patients with relapsed/refractory lymphoma.Four dose groups : 7.5 mg/kg, 15 mg/kg, 22.5 mg/kg and 30 mg/kg ,will be explored according to the 3+3" principle. First, 3 subjects were enrolled. If no DLT occur during the DLT observation period, the next dose group test was conducted;if DLT occurs in 2 or more of the 3 patients in this group, the climbing will be terminated or a lower dose group shall be recommended by the Safety Review Committee ; if DLT occurs in only 1 of the 3 patients, add 3 patient, if 3 patients did not develop DLT, the dose is escalated to the next group; if DLT occurs in 1 or more of the three additional patients, the dose escalation will be terminated or the Safety Review Committee recommends a new lower dose group. Safety Review Committee will be based on the safety and tolerability of every dose group and PK(pharmacokinetics) and PD (pharmacodynamics) data, for the next dose increasing amplitude and dosing cycle are discussed, at the same time also will recommend whether to increase the dose of unplanned group or dosing method and dosing cycle of exploration group.

phase II is the efficacy exploratory part and the efficacy confirmation part. : 5 cohorts will be carried out in parallel to initially evaluate the effectiveness of recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection.

The 5 cohorts in the efficacy exploration part are:

Cohort 1: Relapsed/refractory diffuse large B-cell lymphoma; Cohort 2: Relapsed/refractory peripheral T-cell lymphoma; Cohort 3: Relapsed/refractory classic Hodgkin's lymphoma; Cohort 4: Relapsed/refractory mantle cell lymphoma; Cohort 5: Relapsed/refractory follicular lymphoma and marginal zone lymphoma; In the efficacy exploration part, each cohort will enroll 15 subjects, a total of 5 cohorts, and 75 patients are expected to be enrolled.

According to the analysis of the Safety Review Committee , the cohort with the efficacy enters the efficacy confirmation part, and the number of subjects in the efficacy confirmation part is re-estimated according to statistics; the cohort without the efficacy trend is enrolled up to 15 patients (according to the analysis of the Safety Review Committee , the group can be stopped midway).

In the second phase of efficacy confirmation , one or two indications with better safety and efficacy among the 5 cohorts in the efficacy exploration part will be selected to further confirm the efficacy of recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection And safety. ;

Related Conditions & MeSH terms

• Lymphoma
• Relapsed/Refractory Lymphoma

• NCT number: NCT05189093
• Study type: Interventional
• Source: Waterstone Hanxbio Pty Ltd
• Contact: qian jiang
• Phone: +8618600110741
• Email: qian.jiang@hanxbio.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 31, 2021
• Completion date: August 30, 2023