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Trial Title:
UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
NCT ID:
NCT05731219
Condition:
Relapsed/Refractory Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Conditions: Keywords:
B7-H3 target
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
UTAA06 injection
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
B7-H3 target, CAR gene modified gdT cell injection
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.
Arm group label:
B7-H3 target, CAR gene modified gdT cell injection
Other name:
UTAA06 injection
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18, regardless of gender;
2. Expected survival time ≥ 3 months;
3. ECOG score 0-1;
4. At screening, acute myeloid leukemia was definitely diagnosed, and B7-H3 expression
in tumor cells was positive;
5. Patients with relapsed/refractory acute myeloid leukemia who failed to receive
second-line or above standard treatment;
6. Coagulation function, liver and kidney function, heart and lung function meet the
following requirements:
1. Prothrombin time/international standardized ratio (PT/INR) and partial
thromboplastin time (PTT) ≤ 1.5 ULN;
2. Creatinine ≤ 1.5 ULN;
3. Left ventricular ejection fraction ≥ 50%, no pericardial effusion is found in
echocardiography, and no clinically significant abnormal wave band is found in
electrocardiogram;
4. Indoor baseline blood oxygen saturation>92%;
5. 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；
7. Be able to understand the test and have signed the informed consent form.
Exclusion Criteria:
1. 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;
2. 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;
3. 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;
4. Unstable systemic diseases judged by the investigator: including but not limited to
severe liver, kidney or metabolic diseases requiring drug treatment;
5. 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);
6. 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;
7. 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);
8. Participated in other clinical studies within 1 month before screening;
9. During screening, there was evidence of central nervous system invasion, such as
tumor cells detected in cerebrospinal fluid or imaging indicating central
infiltration;
10. Those who have graft versus host reaction and need immunosuppressants;
11. People with epilepsy history or other central nervous system diseases;
12. Patients with primary immunodeficiency disease;
13. According to the judgment of the researcher, it does not conform to the situation of
cell preparation;
14. Other researchers think it is not suitable to be included in the group.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital， Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
He Huang, doctor
Phone:
13605714822
Email:
hehuangyu@126.com
Start date:
September 26, 2022
Completion date:
September 26, 2025
Lead sponsor:
Agency:
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Agency class:
Industry
Source:
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05731219
