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The main research objective is to evaluate the safety, tolerability, and pharmacokinetic characteristics of UTAA09 cell preparation in the treatment of relapsed/refractory B-cell non Hodgkin's lymphoma patients. The secondary research objective is to explore the clinical efficacy of UTAA09 injection after administration and to explore the content of CD19 positive B cells in peripheral blood after UTAA09 injection administration.
Single dose, single arm trial, exploring the initial 28 day safety and efficacy of the investigational drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B cell injection targeting CD19 chimeric antigen receptor | Experimental | UTAA09 Injection The subjects, who sign the informed consent forms and been screeneinclusion/exclusion criteria, will be assigned into 3 x 108~1 x 1010 CD19-CAR - γδT cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UTAA09 injection | Biological | The subjects, who sign the informed consent forms and been screeneinclusion/exclusion criteria, will be assigned into 3 x 108~1 x 1010 CD19-CAR - γδT cells. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of dose limiting toxicity (DLT ) | The incidence, severity, and types of dose limiting toxicity | 28 days after infusion |
| The incidence of TEAEs | The incidence, severity, and types of adverse events that occur during treatment | 28 days after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Evaluate the overall response rate based on the efficacy criteria of Lugano 2014 | 24 months after infusion |
| PFS | Evaluate the progression free survival based on the efficacy criteria of Lugano 2014 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Fan, Doctor | Contact | 86-13813976136 | fanlei3014@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xu Huang, Bachelor | The First Affiliated Hospital with Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PersonGen.Anke Cellular Therapeutice Co., Ltd. | Recruiting | Hefei | Anhui | 230088 | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
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UTAA09 injection
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| 24 months after infusion |
| OS | Evaluate the overall survival based on the efficacy criteria of Lugano 2014 | 24 months after infusion |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |