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| Name | Class |
|---|---|
| Fudan University | OTHER |
| Shanghai 10th People's Hospital | OTHER |
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The primary objective of this study is to evaluate the safety of Neo-T in combination with anti-PD1 in patients with solid tumors.
The secondary objective of this study is to evaluate preliminarily the effect of Neo-T in combination with anti-PD1 in patients with solid tumors.
This is a single arm, open label and non-randomized clinical study.
6 to12 patients will be enrolled to assess the safety and explore recommended dose of Neo-T combined with anti-PD1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment of Neo-T and anti-PD1 | Experimental | Dose escalation will use a 3+3 design and will enroll cohorts of 3-6 patients with MEL or NSCLC at escalating doses of 1.2×10^9 cells and 3.6×10^9 cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neo-T | Biological | Patients will receive Neo-T iv on day 0. Three times of cell infusion with an interval of 7 days constitute a cycle,maximum four cycles of treatment for patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as assessed by CTCAE v5.0. | Keep records the adverse events experienced by subjects in 28 days after the first infusion. | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | ORR is defined as the proportion of participants with tumor size reduction(CR,PR) assessed by RECIST 1.1 and iRECIST. | one year |
| Disease Control Rate(DCR) | DCR is defined as the proportion of participants with tumor size reduction(CR,PR) and stable disease(SD) assessed by RECIST 1.1 and iRECIST. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Zhang, Doctor | Contact | 021-64175590 | syner2000@163.com | |
| Qing Xu, Doctor | Contact | 021-66300588 | xuqingmd@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Zhang, Doctor | Fudan University | Principal Investigator |
| Yong Chen, Doctor | Fudan University | Principal Investigator |
| Qing Xu, Doctor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37301885 | Background | Li D, Chen C, Li J, Yue J, Ding Y, Wang H, Liang Z, Zhang L, Qiu S, Liu G, Gao Y, Huang Y, Li D, Zhang R, Liu W, Wen X, Li B, Zhang X, Zhang X, Xu RH. A pilot study of lymphodepletion intensity for peripheral blood mononuclear cell-derived neoantigen-specific CD8 + T cell therapy in patients with advanced solid tumors. Nat Commun. 2023 Jun 10;14(1):3447. doi: 10.1038/s41467-023-39225-7. | |
| 35661819 |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D007262 | Infusions, Intravenous |
| C000656314 | toripalimab |
| C000707970 | tislelizumab |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| Toripalimab | Combination Product | 3mg/kg iv; Within 7 days after the first PBMC collection (day-38±3), the first dose was administered, and thereafter every 2 weeks. Toripalimab is recommended for patients with Melanoma. |
|
|
| Tislelizumab | Combination Product | 200mg iv; Within 7 days after the first PBMC collection (day-38±3), the first dose was administered, and thereafter every 3 weeks. Tislelizumab is recommended for patients with NSCLC or other tumor types. |
|
|
| one year |
| Overall survival(OS) | The time from the first infusion of Investigational Product until death. | one year |
| Progression-free survival(PFS) | PFS is defined as the time from the first infusion of Investigational Product until objective tumor progression, as assessed by RECIST 1.1 and iRECIST, or death, whichever occurs first. | one year |
| Duration of Response(DOR) | DOR refers to the period from the first evaluation of tumor as CR or PR to the first evaluation as PD(Progressive Disease) per RECIST1.1 and iRECIST. | one year |
| Shanghai 10th People's Hospital |
| Principal Investigator |
| Shanghai Tenth People's Hospital | Recruiting | Shanghai | China |
|
| Background |
| Guo Z, Yuan Y, Chen C, Lin J, Ma Q, Liu G, Gao Y, Huang Y, Chen L, Chen LZ, Huang YF, Wang H, Li B, Chen Y, Zhang X. Durable complete response to neoantigen-loaded dendritic-cell vaccine following anti-PD-1 therapy in metastatic gastric cancer. NPJ Precis Oncol. 2022 Jun 3;6(1):34. doi: 10.1038/s41698-022-00279-3. |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007263 |
| Infusions, Parenteral |