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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gdT cell injection targeting B7-H3 chimeric atigen receptor | Experimental | UTAA06 injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gdT cell injection targeting B7-H3 chimeric antigen receptor | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate anti-tumor activity (overall survival) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heng Mei, Doctor | Contact | +86-13886160811 | mayheng@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Heng Mei, Doctor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PersonGen Anke Cellular Therapeutice Co., Ltd. | Recruiting | Hefei | Anhui | 230088 | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
|
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) | 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 |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |