Relapsed/Refractory Acute Myeloid LeukemiaEarly Phase 1NCT05722171
Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
A Early Phase 1 study testing gdT cell injection targeting B7-H3 chimeric antigen receptor in people with Relapsed/Refractory Acute Myeloid Leukemia, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
This is a single-arm, open-label, dose-escalation study to explore the safety, efficacy, and cytodynamic characteristics of the drug, and to initially observe the efficacy of the drug in subjects with relapsed/refractory B7-H3-positive acute myeloid cell line leukemia. 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?
- gdT cell injection targeting B7-H3 chimeric antigen receptor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2022to 27 Dec 2024
- Phase
- Early 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
- (1) Age≥ 18 years old, gender is not limited;
- (2) expected survival time≥ 3 months;
- (3) ECOG score 0-1 points;
- (4) Acute myeloid leukemia was clearly diagnosed during screening, and tumor cells were positive for B7-H3 expression;
- (5) Subjects with relapsed/refractory acute myeloid leukemia who have failed standard treatment or lack effective treatment methods.
- (6) Coagulation function, liver and kidney function, cardiopulmonary function meet requirements.
- (7) Be able to understand the trial and have signed the informed consent form.
Who cannot join
- (1) Malignant tumors other than acute myeloid leukemia within 5 years before screening;
- (2) Those who test positive for virus and syphilis;
- (3) Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association [NYHA] classification≥ grade III), severe arrhythmia;
- (4) Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
- (5) Active infection or uncontrollable infection requiring systemic treatment within 7 days prior to screening;
- (6) pregnant or lactating women, female subjects who planned to become pregnant within 2 years after cell reinfusion or male subjects whose partners planned to become pregnant within 2 years after their cell reinfusion;
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- (7) Subjects who were receiving systemic steroid therapy within 7 days prior to the year or who were judged by the investigator to require long-term systemic steroid therapy during treatment (other than inhalation or topical use);
- (8) Have participated in other clinical studies within 1 month before screening;
- (9) There was evidence of central nervous system invasion during subject screening, such as tumor cells detected in cerebrospinal fluid or imaging showing central infiltration;
- (10) Those who have graft-versus-host response and need to use immunosuppressants;
- (11) Those with a history of epilepsy or other central nervous system diseases;
- (12) Patients with primary immunodeficiency diseases;
- (13) situations that other investigators consider unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PersonGen Anke Cellular Therapeutice Co., Ltd.
Hefei, Anhui, 230088
Huimin Meng, Doctor, +86-18015580390, huimin.meng@persongen.com
About this study
Official title: Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute
This is a single-arm, open-label, dose-escalation study to explore the safety, efficacy, and cytodynamic characteristics of the drug, and to initially observe the efficacy of the drug in subjects with relapsed/refractory B7-H3-positive acute myeloid cell line leukemia.
Read the detailed description
Eligible subjects will receive 1.0×10^8 CAR gdT, 2.0×10^8 CAR gdT, 4.0×10^8 CAR gdT, or additional doses may be added at the discretion of investigator and sponsor.
- Being tested
- gdT cell injection targeting B7-H3 chimeric antigen receptor
- 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.
gdT cell injection targeting B7-H3 chimeric antigen receptorBiological
Also called UTAA06 injection
The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 1E8, 2E8 and 4E8 CAR-gdT groups in order of sequence. And the subjects will be administered once.
| Study group | Role | What they receive |
|---|---|---|
| gdT cell injection targeting B7-H3 chimeric atigen receptor | Experimental | UTAA06 injection Receives: Biological: gdT cell injection targeting B7-H3 chimeric antigen receptor |
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 UTAA06 infusion therapy to death (due to any cause)
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 posted10 Feb 2023
- Study start27 Dec 2022
- Primary completion27 Dec 2023 (estimated)
- Study completion27 Dec 2024 (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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heng Mei, Doctor, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722171
- Sponsor's protocol ID
- PG-p002-015
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 10 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 10 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
- ClinicalTrials.gov ID
- NCT05722171
- Acronym / sponsor ID
- PG-p002-015
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 27 Dec 2023 (estimated)
- Study completion
- 27 Dec 2024 (estimated)
- First posted
- 10 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.
This is a single-arm, open-label, dose-escalation study to explore the safety, efficacy, and cytodynamic characteristics of the drug, and to initially observe the efficacy of the drug in subjects with relapsed/refractory B7-H3-positive acute myeloid cell line leukemia.
Detailed description
Eligible subjects will receive 1.0×10^8 CAR gdT, 2.0×10^8 CAR gdT, 4.0×10^8 CAR gdT, or additional doses may be added at the discretion of investigator and sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gdT cell injection targeting B7-H3 chimeric atigen receptor | Experimental | Biological: gdT cell injection targeting B7-H3 chimeric antigen receptorUTAA06 injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- (1) Age≥ 18 years old, gender is not limited;
- (2) expected survival time≥ 3 months;
- (3) ECOG score 0-1 points;
- (4) Acute myeloid leukemia was clearly diagnosed during screening, and tumor cells were positive for B7-H3 expression;
- (5) Subjects with relapsed/refractory acute myeloid leukemia who have failed standard treatment or lack effective treatment methods.
Key exclusion criteria (13 listed)
- (1) Malignant tumors other than acute myeloid leukemia within 5 years before screening;
- (2) Those who test positive for virus and syphilis;
- (3) Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association [NYHA] classification≥ grade III), severe arrhythmia;
- (4) Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
- (5) Active infection or uncontrollable infection requiring systemic treatment within 7 days prior to screening;
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 |
|---|---|---|
| gdT cell injection targeting B7-H3 chimeric antigen receptorAlso: UTAA06 injectionThe subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 1E8, 2E8 and 4E8 CAR-gdT groups in order of sequence. And the subjects will be administered once. | Biological | gdT cell injection targeting B7-H3 chimeric atigen receptor |
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 10 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.
Heng Mei, Doctor principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing gdT cell injection targeting B7-H3 chimeric antigen receptor 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 7 inclusion and 13 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 10 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Heng Mei, Doctor (+86-13886160811, mayheng@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 10 Feb 2023.