Relapsed/Refractory Acute Myeloid LeukemiaPhase 1NCT05731219
UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1 study testing B7-H3 target, CAR gene modified gdT cell injection in people with Relapsed/Refractory Acute Myeloid Leukemia, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Acute Myeloid Leukemia
- What is being tested?
- B7-H3 target, CAR gene modified gdT cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2022to 26 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital， Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
He Huang, doctor, 13605714822, hehuangyu@126.com
About this study
Official title: Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
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.
Read the 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.
- Being tested
- B7-H3 target, CAR gene modified gdT cell injection
- Keywords
- B7-H3 target
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B7-H3 target, CAR gene modified gdT cell injectionBiological
Also called 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 × 108，3.0 × 108 and 6.0 × 108 CAR gdT groups were administered once.
| Study group | Role | What they receive |
|---|---|---|
| B7-H3 target, CAR gene modified gdT cell injection | Experimental | 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. Receives: Biological: B7-H3 target, CAR gene modified gdT cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the safety after UTAA06 injection treatment (Safety)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: About 2 years
Secondary outcomes (3)
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
Measured: About 2 years
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).
Measured: About 2 years
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.
Measured: About 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start26 Sep 2022
- Primary completion26 Sep 2023 (estimated)
- Study completion26 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by PersonGen BioTherapeutics (Suzhou) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- UTAA06 injection
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- He Huang, doctor, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731219
- Sponsor's protocol ID
- PG-pCAR-gdT-TAA06-017
- Status last verified
- Feb 2023
- First submitted
- 31 Jan 2023
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05731219
- Acronym / sponsor ID
- PG-pCAR-gdT-TAA06-017
- Keywords
- B7-H3 target
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 26 Sep 2023 (estimated)
- Study completion
- 26 Sep 2025 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- UTAA06 injection
| Arm | Type | Receives |
|---|---|---|
| B7-H3 target, CAR gene modified gdT cell injection | Experimental | Biological: B7-H3 target, CAR gene modified gdT cell injectionUTAA06 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B7-H3 target, CAR gene modified gdT cell injectionAlso: UTAA06 injectionAfter 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. | Biological | B7-H3 target, CAR gene modified gdT cell injection |
Primary outcome
Assessment of the safety after UTAA06 injection treatment (Safety)
Time frame: About 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
3 secondary outcomes
To evaluate anti-tumor activity (overall survival)
Time frame: About 2 years
To evaluate anti-tumor activity (duration of response)
Time frame: About 2 years
To evaluate anti-tumor activity (progression free survival)
Time frame: About 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
He Huang, doctor principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing B7-H3 target, CAR gene modified gdT cell injection in people with Relapsed/Refractory Acute Myeloid Leukemia, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact He Huang, doctor (13605714822, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the safety after UTAA06 injection treatment (Safety) (time frame: About 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.