- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05722171
Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
January 31, 2023 updated by: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
10
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Heng Mei, Doctor
- Phone Number: +86-13886160811
- Email: mayheng@126.com
Study Locations
-
-
Anhui
-
Hefei, Anhui, China, 230088
- Recruiting
- PersonGen Anke Cellular Therapeutice Co., Ltd.
-
Contact:
- Huimin Meng, Doctor
- Phone Number: +86-18015580390
- Email: huimin.meng@persongen.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- (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.
Exclusion Criteria:
- (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;
- (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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: gdT cell injection targeting B7-H3 chimeric atigen receptor
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
About 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate anti-tumor activity (overall survival)
Time Frame: About 2 years
|
Defined as the time from start of UTAA06 UTAA06 infusion therapy to death (due to any cause)
|
About 2 years
|
To evaluate anti-tumor activity (duration of response)
Time Frame: About 2 years
|
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).
|
About 2 years
|
To evaluate anti-tumor activity (progression free survival)
Time Frame: About 2 years
|
Defined as the time from the start of UTAA06 infusion therapy to the first disease progression or recurrence or death from any cause.
|
About 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 27, 2022
Primary Completion (ANTICIPATED)
December 27, 2023
Study Completion (ANTICIPATED)
December 27, 2024
Study Registration Dates
First Submitted
January 16, 2023
First Submitted That Met QC Criteria
January 31, 2023
First Posted (ACTUAL)
February 10, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 10, 2023
Last Update Submitted That Met QC Criteria
January 31, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PG-p002-015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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