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This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors.
This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors (especially head and neck cancer, non-driver gene sensitive mutation of non-small cell lung cancer). The investigators plan to enroll about 9 patients to explore the dose limited toxicity or recommended dose for future study of Neo-DC vaccine. The study is designed as 3 plus 3 model, and set two dose levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental | Patients will received DC vaccine infusions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC Vaccine | Drug | Patients will receive Neo-DC vaccine infusion either by dose 1 (1×10^7 cells/time) or dose 2 (5×10^7 cells/time) every 7 days, four cell infusions are one treatment cycle. The dose limited toxity observation time is within 28 days after the first Neo-DC vaccine infusion. If the efficacy is evaluated as clinical benefit (CR/PR/SD) or immune unconfirmed progress ( iUPD), treatment cycle can be continued until the completion of four Neo-DC vaccine administrations or disease progression (iCPD by iRECIST) or start new anti-tumor treatment or stop treatment by other reasons. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | The incidence and severity of adverse events | Within 28 days after the first Neo-DC vaccine cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The partial remission (PR) and complete remission rate (CR) | up 2 years |
| Dose limited toxicity | Dose limited toxicity within 28 days after the first Neo-DC vaccine cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| IFN-γ activity detected by ELISPOT, cell factor and T cell subsets detection. | IFN-γ activity detected by ELISPOT, cell factor detected by ELISA, and T cell subsets detection by flow cytometry. | up 2 years |
| iDCR |
Inclusion Criteria:
Exclusion Criteria:
Pregnant or lactating women.
Patients with a history of severe immediate allergies to the cells and any drugs used in this study.
Those with a history of organ transplantation.
Known central nervous system metastasis.
Any active autoimmune disease or any autoimmune disease that has been determined by the researchers to be unsuitable for this study.
Uncontrolled concomitant diseases or infectious diseases, such as the need for systemic antibiotics within 2 weeks before enrollment.
Suffering from severe liver and kidney function damage (liver, kidney treatment but still not controllable, biochemical indicators can not meet the inclusion criteria of NO.11, or can not control the diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or poor drug control of hypertension ( systolic blood pressure more than 160mmHg and/or diastolic blood pressure more than 90mmHg), or with clinical Bed meaning (e.g. activity ) of cardiovascular and cerebrovascular diseases, such as cerebrovascular accident (6 months before signing informed consent) unstable angina, myocardial infarction (within 6 months before signing informed consent), unstable angina, New York Heart Association, or any circumstances which, in the opinion of the researcher, may increase the risk of the subject or interfere with the results of the test.
Subjects planned to receive sugar within 4 weeks before the first Neo-DCV injection and during the study period due to certain conditions.
Corticosteroids (prednisone or the same drug dose less than 10mg/day ) or other immunosuppressive agents were excluded.
Subjects were scheduled to receive Neo-DCV injection within 4 weeks before the first administration and during the study period due to certain conditions.
The researchers assessed that the subjects were unable or unwilling to comply with the requirements of the study protocol.
The defects of antigen presentation, antigen recognition and cell killing related genes were detected by sequencing.
There was a history of other malignant tumors in the past 5 years, except for curable basal cell carcinoma, papillary thyroid carcinoma, and uterus.
Subjects have any disease or medical condition that may affect the evaluation of the safety or efficacy of the study drug.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongmei Ji, M.D | Contact | 021-64175590 | 83650 | jidongmei2000@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xianghua Wu, M.D | Fudan University | Principal Investigator |
| Qinghai Ji, M.D | Fudan University | Principal Investigator |
| Dongmei Ji, M.D |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200020 | China |
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| ID | Term |
|---|---|
| C000706173 | lentiviral minigene vaccine of COVID-19 coronavirus |
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This is a single arm, single center, open label study designed as "3+3" model to explore the MTD and DLT of personalized self-DC vaccine targeting neoantigen in treatment of advanced solid tumor.
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| Within 28 days after the first Neo-DC vaccine cell infusion |
iDCR by iRECIST
| up 2 years |
| iPFS | iPFS by iRECIST | up 2 years |
| iDOR | iDOR by iRECIST | up 2 years |
| Fudan University |
| Principal Investigator |