search
Back to results

UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

Primary Purpose

Relapsed/Refractory Acute Myeloid Leukemia

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
B7-H3 target, CAR gene modified gdT cell injection
Sponsored by
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Acute Myeloid Leukemia focused on measuring B7-H3 target

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18, regardless of gender; Expected survival time ≥ 3 months; ECOG score 0-1; At screening, acute myeloid leukemia was definitely diagnosed, and B7-H3 expression in tumor cells was positive; Patients with relapsed/refractory acute myeloid leukemia who failed to receive second-line or above standard treatment; Coagulation function, liver and kidney function, heart and lung function meet the following requirements: Prothrombin time/international standardized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 1.5 ULN; Creatinine ≤ 1.5 ULN; Left ventricular ejection fraction ≥ 50%, no pericardial effusion is found in echocardiography, and no clinically significant abnormal wave band is found in electrocardiogram; Indoor baseline blood oxygen saturation>92%; Total bilirubin ≤ 2 × ULN; ALT and AST ≤ 2.5 × ULN; The investigator judges the abnormality of ALT and AST caused by diseases (such as liver infiltration or bile duct obstruction), and the index can be broadened to ≤ 5 × ULN; Be able to understand the test and have signed the informed consent form. Exclusion Criteria: In addition to adequately treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery, patients with malignant tumors other than acute myeloid leukemia in the first 5 years of screening; Hepatitis B surface antigen (HBsAg) positive and DNA positive; Hepatitis B core antibody (HBcAb) was positive and the copy number of HBV DNA in peripheral blood was greater than the lower limit of measurability; Hepatitis C virus (HCV) antibody positive and hepatitis C virus (HCV) RNA positive in peripheral blood; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Syphilis test positive; Serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), and serious arrhythmia; Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment; Within 7 days before screening, there is active infection or uncontrollable infection requiring systemic treatment (except for mild genitourinary system infection and upper respiratory tract infection); Pregnant or lactating women, female subjects planning pregnancy within 2 years after cell reinfusion or male subjects planning pregnancy within 2 years after their partners' cell reinfusion; Subjects who are receiving systemic steroid treatment within 7 days before screening or need long-term use of systemic steroid treatment during treatment determined by the investigator (except for inhalation or local use); Participated in other clinical studies within 1 month before screening; During screening, there was evidence of central nervous system invasion, such as tumor cells detected in cerebrospinal fluid or imaging indicating central infiltration; Those who have graft versus host reaction and need immunosuppressants; People with epilepsy history or other central nervous system diseases; Patients with primary immunodeficiency disease; According to the judgment of the researcher, it does not conform to the situation of cell preparation; Other researchers think it is not suitable to be included in the group.

Sites / Locations

  • The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

B7-H3 target, CAR gene modified gdT cell injection

Arm Description

UTAA06 injection After the subjects who signed the informed consent form were screened by the inclusion/exclusion criteria, the qualified subjects will enter 1.0 in order of priority × 10^8,3.0 × 10^8 and 6.0 × 10^8 CAR gdT groups were administered once.

Outcomes

Primary Outcome Measures

Assessment of the safety after UTAA06 injection treatment (Safety)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

Secondary Outcome Measures

To evaluate anti-tumor activity (overall survival)
Defined as the time from start of UTAA06 infusion therapy to death (due to any cause)myeloid leukemia
To evaluate anti-tumor activity (duration of response)
Defined as the time from the first tumor assessment of CR or PR, CR or CRi to the first assessment of disease recurrence or progression or death (due to any cause).
To evaluate anti-tumor activity (progression free survival)
Defined as the time from the start of UTAA06 infusion therapy to the first disease progression or recurrence or death from any cause.

Full Information

First Posted
January 31, 2023
Last Updated
February 15, 2023
Sponsor
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05731219
Brief Title
UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Official Title
Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
September 26, 2023 (Anticipated)
Study Completion Date
September 26, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PersonGen BioTherapeutics (Suzhou) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Main research purpose: Evaluate the safety and tolerance of UTAA06 injection in the treatment of patients with relapsed/refractory acute myeloid leukemia. Secondary research purpose: Evaluate the expansion and persistence of gdT cells targeting B7-H3 chimeric antigen receptor after UTAA06 injection administration in vivo; Evaluate the efficacy of UTAA06 injection in the treatment of patients with relapsed/refractory acute myeloid leukemia; Evaluate the content of B7-H3 positive cells in the peripheral blood after administration of UTAA06 injection; Evaluate the immunogenicity of UTAA06 injection.
Detailed Description
This study is a single arm, open label, dose increasing study to explore the characteristics of drug safety, tolerance and cell kinetics, and preliminarily observe the efficacy of the study drug in patients with relapsed/refractory B7-H3 positive acute myeloid leukemia, so as to explore the formal clinical appropriate dose. After the subjects who signed the informed consent form were screened by the inclusion/exclusion criteria, the qualified subjects will enter 1.0 in order of priority × 108,3.0 × 108 and 6.0 × 108 CAR gdT groups were administered once. The "3+3" design was adopted in the dose increasing study, that is, 3-6 subjects in each group completed a single dose. After the last subject in each dose group completed the dose limiting toxicity (DLT) assessment window 28 days after the single administration, the next dose group can be started after the Safety Monitoring Committee (SRC) agrees to enter the next dose group based on the evaluation of clinical safety data. When 1 DLT occurs in 3 subjects in a certain dose group, 3 subjects need to be added in the same dose group (up to 6 subjects in this dose group complete DLT evaluation): if the added 3 subjects have no DLT, the dose will continue to increase; If one of the three additional subjects has DLT, stop the dose increase; If more than one of the three additional subjects has DLT, stop the dose increase, and at the same time, reduce one dose to continue the DLT evaluation of the three subjects. The SRC can decide whether to increase or decrease the dose groups or adjust the dose of groups according to the pharmacokinetic results obtained during the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Acute Myeloid Leukemia
Keywords
B7-H3 target

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
UTAA06 injection
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
B7-H3 target, CAR gene modified gdT cell injection
Arm Type
Experimental
Arm Description
UTAA06 injection After the subjects who signed the informed consent form were screened by the inclusion/exclusion criteria, the qualified subjects will enter 1.0 in order of priority × 10^8,3.0 × 10^8 and 6.0 × 10^8 CAR gdT groups were administered once.
Intervention Type
Biological
Intervention Name(s)
B7-H3 target, CAR gene modified gdT cell injection
Other Intervention Name(s)
UTAA06 injection
Intervention Description
After the subjects who signed the informed consent form were screened by the inclusion/exclusion criteria, the qualified subjects will enter 1.0 in order of priority × 108,3.0 × 108 and 6.0 × 108 CAR gdT groups were administered once.
Primary Outcome Measure Information:
Title
Assessment of the safety after UTAA06 injection treatment (Safety)
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time Frame
About 2 years
Secondary Outcome Measure Information:
Title
To evaluate anti-tumor activity (overall survival)
Description
Defined as the time from start of UTAA06 infusion therapy to death (due to any cause)myeloid leukemia
Time Frame
About 2 years
Title
To evaluate anti-tumor activity (duration of response)
Description
Defined as the time from the first tumor assessment of CR or PR, CR or CRi to the first assessment of disease recurrence or progression or death (due to any cause).
Time Frame
About 2 years
Title
To evaluate anti-tumor activity (progression free survival)
Description
Defined as the time from the start of UTAA06 infusion therapy to the first disease progression or recurrence or death from any cause.
Time Frame
About 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18, regardless of gender; Expected survival time ≥ 3 months; ECOG score 0-1; At screening, acute myeloid leukemia was definitely diagnosed, and B7-H3 expression in tumor cells was positive; Patients with relapsed/refractory acute myeloid leukemia who failed to receive second-line or above standard treatment; Coagulation function, liver and kidney function, heart and lung function meet the following requirements: Prothrombin time/international standardized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 1.5 ULN; Creatinine ≤ 1.5 ULN; Left ventricular ejection fraction ≥ 50%, no pericardial effusion is found in echocardiography, and no clinically significant abnormal wave band is found in electrocardiogram; Indoor baseline blood oxygen saturation>92%; Total bilirubin ≤ 2 × ULN; ALT and AST ≤ 2.5 × ULN; The investigator judges the abnormality of ALT and AST caused by diseases (such as liver infiltration or bile duct obstruction), and the index can be broadened to ≤ 5 × ULN; Be able to understand the test and have signed the informed consent form. Exclusion Criteria: In addition to adequately treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery, patients with malignant tumors other than acute myeloid leukemia in the first 5 years of screening; Hepatitis B surface antigen (HBsAg) positive and DNA positive; Hepatitis B core antibody (HBcAb) was positive and the copy number of HBV DNA in peripheral blood was greater than the lower limit of measurability; Hepatitis C virus (HCV) antibody positive and hepatitis C virus (HCV) RNA positive in peripheral blood; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Syphilis test positive; Serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), and serious arrhythmia; Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment; Within 7 days before screening, there is active infection or uncontrollable infection requiring systemic treatment (except for mild genitourinary system infection and upper respiratory tract infection); Pregnant or lactating women, female subjects planning pregnancy within 2 years after cell reinfusion or male subjects planning pregnancy within 2 years after their partners' cell reinfusion; Subjects who are receiving systemic steroid treatment within 7 days before screening or need long-term use of systemic steroid treatment during treatment determined by the investigator (except for inhalation or local use); Participated in other clinical studies within 1 month before screening; During screening, there was evidence of central nervous system invasion, such as tumor cells detected in cerebrospinal fluid or imaging indicating central infiltration; Those who have graft versus host reaction and need immunosuppressants; People with epilepsy history or other central nervous system diseases; Patients with primary immunodeficiency disease; According to the judgment of the researcher, it does not conform to the situation of cell preparation; Other researchers think it is not suitable to be included in the group.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
He Huang, doctor
Phone
13605714822
Email
hehuangyu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huimin Meng, doctor
Phone
18015580390
Email
huimin.meng@persongen.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
He Huang, doctor
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He Huang, doctor
Phone
13605714822
Email
hehuangyu@126.com

12. IPD Sharing Statement

Learn more about this trial

UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

We'll reach out to this number within 24 hrs