Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
1 other identifier
interventional
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Dec 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 27, 2022
CompletedFirst Submitted
Initial submission to the registry
January 16, 2023
CompletedFirst Posted
Study publicly available on registry
February 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2024
CompletedFebruary 10, 2023
January 1, 2023
1 year
January 16, 2023
January 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of the safety after UTAA06 injection treatment (Safety)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
About 2 years
Secondary Outcomes (3)
To evaluate anti-tumor activity (overall survival)
About 2 years
To evaluate anti-tumor activity (duration of response)
About 2 years
To evaluate anti-tumor activity (progression free survival)
About 2 years
Study Arms (1)
gdT cell injection targeting B7-H3 chimeric atigen receptor
EXPERIMENTALUTAA06 injection
Interventions
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.
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PersonGen Anke Cellular Therapeutice Co., Ltd.
Hefei, Anhui, 230088, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heng Mei, Doctor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2023
First Posted
February 10, 2023
Study Start
December 27, 2022
Primary Completion
December 27, 2023
Study Completion
December 27, 2024
Last Updated
February 10, 2023
Record last verified: 2023-01