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CLDN 18.2 chimeric antigen receptor T cells Clinical research plan for the treatment of recurrent or refractory pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY011 | Biological | Targeting CLDN 18.2 Car-T injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Response rate(ORR) | the proportion of patients with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria | 1month |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival(PFS) | Survival witouth observed progression at 2 years | 1 years |
| Disease Control Rate(DCR) | DCR (CR+PR+SD) by RECIST v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | 221000 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| 1 years |
| Duration of Response (DOR) | DOR was defined as the time from the first documented a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) to progressive disease (PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. | 1 years |
| Overal survival (OS) | survival at 5 years | 5 years |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | AEs according to CTCAE v 5.0. | 1 year |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |