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| Name | Class |
|---|---|
| Hangzhou Neoantigen Therapeutics Co., Ltd. | INDUSTRY |
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This research study is evaluating a new type of cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for advanced malignant tumor. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of Chinese patients with advanced malignant cancer, so as to provide a new personalized therapeutic strategy for advanced pancreatic cancer patients.
It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iNeo-Vac-P01 | Experimental | Personal Cancer Vaccine: iNeo-Vac-P01 (peptides)+ GM-CSF; Peptides: 0.1 or 0.3 mg per peptide given on days 1, 4, 8, 15, 22, 78, and 162 for a total of 7 doses. Additional booster vaccines might be administered depending on ethics and patients' potential benefit. GM-CSF: 40 mcg given 30 minutes before iNeo-Vac-P01. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iNeo-Vac-P01 | Biological | Neoantigen peptides |
| |
| GM-CSF |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | 2 years | |
| Number of participants experiencing clinical and laboratory adverse events (AEs) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Rate | 2 years | |
| Progression Free Survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of CD4/CD8 T lymphocyte subsets | 2 years | |
| The polypeptide antigen - induced IFN-γ T cells responses | 2 years | |
| Peripheral blood T cell receptor sequencing analysis |
Inclusion Criteria:
neutrophil count≥1.5×109/L
hemoglobin≥10g/dL
platelet count≥100×109/L
Total bilirubin is less than or equal to 1.5 times the upper limit of normal value (ULN)
AST and ALT is less than or equal to 2.5 times the upper limit of normal value
Serum creatinine and urea nitrogen (BUN) is less than or equal to 1.5 times the upper limit of normal value
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20473937 | Background | Weden S, Klemp M, Gladhaug IP, Moller M, Eriksen JA, Gaudernack G, Buanes T. Long-term follow-up of patients with resected pancreatic cancer following vaccination against mutant K-ras. Int J Cancer. 2011 Mar 1;128(5):1120-8. doi: 10.1002/ijc.25449. | |
| 28678778 | Background | Ott PA, Hu Z, Keskin DB, Shukla SA, Sun J, Bozym DJ, Zhang W, Luoma A, Giobbie-Hurder A, Peter L, Chen C, Olive O, Carter TA, Li S, Lieb DJ, Eisenhaure T, Gjini E, Stevens J, Lane WJ, Javeri I, Nellaiappan K, Salazar AM, Daley H, Seaman M, Buchbinder EI, Yoon CH, Harden M, Lennon N, Gabriel S, Rodig SJ, Barouch DH, Aster JC, Getz G, Wucherpfennig K, Neuberg D, Ritz J, Lander ES, Fritsch EF, Hacohen N, Wu CJ. An immunogenic personal neoantigen vaccine for patients with melanoma. Nature. 2017 Jul 13;547(7662):217-221. doi: 10.1038/nature22991. Epub 2017 Jul 5. |
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| ID | Term |
|---|---|
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
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| Other |
immune adjuvant |
|
|
| 2 years |
| 36248865 | Derived | Shou J, Mo F, Zhang S, Lu L, Han N, Liu L, Qiu M, Li H, Han W, Ma D, Guo X, Guo Q, Huang Q, Zhang X, Ye S, Pan H, Chen S, Fang Y. Combination treatment of radiofrequency ablation and peptide neoantigen vaccination: Promising modality for future cancer immunotherapy. Front Immunol. 2022 Sep 29;13:1000681. doi: 10.3389/fimmu.2022.1000681. eCollection 2022. |
| 32439700 | Derived | Fang Y, Mo F, Shou J, Wang H, Luo K, Zhang S, Han N, Li H, Ye S, Zhou Z, Chen R, Chen L, Liu L, Wang H, Pan H, Chen S. A Pan-cancer Clinical Study of Personalized Neoantigen Vaccine Monotherapy in Treating Patients with Various Types of Advanced Solid Tumors. Clin Cancer Res. 2020 Sep 1;26(17):4511-4520. doi: 10.1158/1078-0432.CCR-19-2881. Epub 2020 May 21. |
| D016207 |
| Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |