Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors

Study Overview
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Brief Summary
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This single center, single arm and prospective study aimed to establish gene mutation database and select the neoantigens in patients with advanced malignant melanoma, bladder cancer and colorectal cancer. Then, we intended to explore the safety and efficacy of individual tumor antigen-sensitized DC vaccine and their sensitized T cells in these solid cancers.

Official Title
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Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors

Conditions
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Carcinoma, Melanoma, Bladder Cancer, Colorectal Cancer

Intervention / Treatment
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* Biological: Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age:18-75 years Pathologically diagnosed advanced (stage IV) malignant melanoma, bladder cancer or colorectal cancer with measurable lesions; Failed in the previous standard therapy; ECOG PS (Eastern Cooperative Oncology Group performance status) score 0-2 points; The estimated survival period is ≥3 months; Rehabilitate from previous therapy; Adequate organ functions; Patient's written informed consent; Exclusion Criteria: Tumor emergencies; Abnormal coagulation function; Contagious diseases, such as HIV, HBV, HCV infection; Mental disorders; Concomitant tumors; Immunological co-morbidities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tumor antigen-sensitized vaccine and their sensitized T cells<br>Tumor antigen-sensitized vaccine is administrated, 1- week interval, totally 2 times. Then, Neo-antigen DC vaccine and their sensitized T cells are administrated, 2-week interval, totally 5 times. | Biological: Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administration<br>* subcutaneous administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0 | Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0 | 3 months after the last administration of cells | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Overall survival as assessed by RECIST1.1 |  | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma, Bladder Cancer, Colorectal Cancer, tumor neo-antigen DC vaccine, safety, clinical efficacy