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Trial Title:
Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
NCT ID:
NCT05722171
Condition:
Relapsed/Refractory Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
gdT cell injection targeting B7-H3 chimeric antigen receptor
Description:
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.
Arm group label:
gdT cell injection targeting B7-H3 chimeric atigen receptor
Other name:
UTAA06 injection
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
PersonGen Anke Cellular Therapeutice Co., Ltd.
Address:
City:
Hefei
Zip:
230088
Country:
China
Status:
Recruiting
Contact:
Last name:
Huimin Meng, Doctor
Phone:
+86-18015580390
Email:
huimin.meng@persongen.com
Start date:
December 27, 2022
Completion date:
December 27, 2024
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/NCT05722171
