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| Name | Class |
|---|---|
| NeoCura | INDUSTRY |
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The goal of this clinical trial is to learn the safety of tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell in treating advanced gastric cancer in adults. It will also learn if the combined treatment works to treat advanced gastric cancer.
The main questions it aims to answer are:
What medical problems do participants have when using the combined treatment? Does tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell eliminate or shrink the tumor, and can it prolong the patient's survival period?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor vaccine and tumor vaccine induced specific T-cell Arm 1 | Experimental | XH001 injection, 400 μg; Tumor specific T cell injection, Dose 1 |
|
| Tumor vaccine and tumor vaccine induced specific T-cell Arm 2 | Experimental | XH001 injection, 400 μg; Tumor specific T cell injection, Dose 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XH001 Injection | Drug | mRNA tumor neoantigen vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | Incidence and severity of adverse events (AEs), clinically significant abnormal changes in laboratory tests and other examinations (Based on Common Terminology Criteria for Adverse Events [CTCAE] v5.0). | 12 months |
| Dose Limiting Toxicity | Safety events occurring within 28 days after the reinfusion of neoantigen vaccine-induced tumor-specific T cells and related to neoantigen vaccine-induced tumor-specific T cells. | From reinfusion of neoantigen vaccine-induced tumor-specific T cells to 28 days after the reinfusion. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Response Rate | 24 months |
| PFS | Progression-Free Survival | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JIA Wei, MD | Contact | 0086-025-83304616 | jiawei99@nju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37165196 | Background | Rojas LA, Sethna Z, Soares KC, Olcese C, Pang N, Patterson E, Lihm J, Ceglia N, Guasp P, Chu A, Yu R, Chandra AK, Waters T, Ruan J, Amisaki M, Zebboudj A, Odgerel Z, Payne G, Derhovanessian E, Muller F, Rhee I, Yadav M, Dobrin A, Sadelain M, Luksza M, Cohen N, Tang L, Basturk O, Gonen M, Katz S, Do RK, Epstein AS, Momtaz P, Park W, Sugarman R, Varghese AM, Won E, Desai A, Wei AC, D'Angelica MI, Kingham TP, Mellman I, Merghoub T, Wolchok JD, Sahin U, Tureci O, Greenbaum BD, Jarnagin WR, Drebin J, O'Reilly EM, Balachandran VP. Personalized RNA neoantigen vaccines stimulate T cells in pancreatic cancer. Nature. 2023 Jun;618(7963):144-150. doi: 10.1038/s41586-023-06063-y. Epub 2023 May 10. |
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| Tumor vaccine-induced specific T-cell injection | Drug | Adoptive Cell Transfer Therapy product |
|
| DCR | Disease Control Rate | 24 months |
| OS | Overall Survival | 36 months |
| BOR | Best Overall Response | 24 months |
| DOR | Duration of Response | 24 months |