Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors

Sichuan University

Status and phase: Unknown; Phase 1

Conditions: Bladder Cancer; Melanoma; Carcinoma; Colorectal Cancer

Treatments: Biological: Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administration

Study type: Interventional

Funder types: Other

Identifiers

NCT05235607

PITTN2021

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Tumor antigen-sensitized vaccine and their sensitized T cells

Experimental group

Description:

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.

Treatment:

Biological: Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administration