Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-29 @ 3:35 AM
Study NCT ID:
NCT05189093
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2021-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recombinant Humanized Anti-CD47/PD-1 Bifunctional Antibody HX009 in Patients With Relapsed/Refractory Lymphoma
Sponsor:
Hangzhou Hanx Biopharmaceuticals, Ltd.
Organization:
Study Overview
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
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 .
Detailed Description:
Phase Ib/II efficacy exploration and confirmation phase:
Four cohorts will be conducted in parallel to initially evaluate the recombinant humanized anti-CD47/PD-1 bifunctional anti HX009 injection.
The four cohorts in the efficacy exploration phase are:
Cohort 1: Relapsed/refractory diffuse large B-cell lymphoma; Cohort 2: relapsed/refractory peripheral T-cell lymphoma (except angioimmunoblastic T-cell lymphoma).
(except angioimmunoblastic T-cell lymphoma); Cohort 3: relapsed/refractory follicular lymphoma and relapsed/refractory marginal zone lymphoma; Cohort 4: relapsed/refractory EBV-positive non-Hodgkin's lymphoma. The study will refer to the "Guidelines for Data Monitoring Committees in Drug Clinical Trials (Trial)".
A data monitoring committee will be set up to provide continuous safety monitoring of the study and to provide advice on the dosage and dosing cycle, as well as on the follow-up of the study.
The committee will provide advice on the dosage and cycle of administration, as well as on the decision-making for subsequent extension studies.
Based on the safety data from this study at the 15 mg/kg dose level, during the efficacy exploration phase, the Each cohort will enroll 10-20 subjects, for a total of 4 cohorts, and 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.
dose level first, and after discussion between the sponsor and the DMC, 15 mg/kg dose level will be enrolled if necessary.
The dose level of 15 mg/kg will be enrolled if necessary after discussion between the sponsor and the DMC. Based on the DMC analysis, the no-trend cohort will be enrolled in a maximum of 10 cases (with the possibility of stop enrollment midway).
The Phase II efficacy confirmation phase will select 1-2 cohorts from the 4 cohorts in the efficacy exploration phase of the study with better safety and efficacy.
1-2 indications with better efficacy to further confirm the efficacy and safety of HX009 injection. Based on the safety and efficacy data from Phase I of this study, the number of cases of subjects in the efficacy confirmation phase will be re-estimated based on statistical principles.
The number of cases of subjects in the validation phase will be re-estimated based on statistical
Four cohorts will be conducted in parallel to initially evaluate the recombinant humanized anti-CD47/PD-1 bifunctional anti HX009 injection.
The four cohorts in the efficacy exploration phase are:
Cohort 1: Relapsed/refractory diffuse large B-cell lymphoma; Cohort 2: relapsed/refractory peripheral T-cell lymphoma (except angioimmunoblastic T-cell lymphoma).
(except angioimmunoblastic T-cell lymphoma); Cohort 3: relapsed/refractory follicular lymphoma and relapsed/refractory marginal zone lymphoma; Cohort 4: relapsed/refractory EBV-positive non-Hodgkin's lymphoma. The study will refer to the "Guidelines for Data Monitoring Committees in Drug Clinical Trials (Trial)".
A data monitoring committee will be set up to provide continuous safety monitoring of the study and to provide advice on the dosage and dosing cycle, as well as on the follow-up of the study.
The committee will provide advice on the dosage and cycle of administration, as well as on the decision-making for subsequent extension studies.
Based on the safety data from this study at the 15 mg/kg dose level, during the efficacy exploration phase, the Each cohort will enroll 10-20 subjects, for a total of 4 cohorts, and 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.
dose level first, and after discussion between the sponsor and the DMC, 15 mg/kg dose level will be enrolled if necessary.
The dose level of 15 mg/kg will be enrolled if necessary after discussion between the sponsor and the DMC. Based on the DMC analysis, the no-trend cohort will be enrolled in a maximum of 10 cases (with the possibility of stop enrollment midway).
The Phase II efficacy confirmation phase will select 1-2 cohorts from the 4 cohorts in the efficacy exploration phase of the study with better safety and efficacy.
1-2 indications with better efficacy to further confirm the efficacy and safety of HX009 injection. Based on the safety and efficacy data from Phase I of this study, the number of cases of subjects in the efficacy confirmation phase will be re-estimated based on statistical principles.
The number of cases of subjects in the validation phase will be re-estimated based on statistical
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: