Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors

Phase 1

• Conditions: Bladder Cancer; Carcinoma; Colorectal Cancer; Melanoma
• Interventions: Biological: Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administration

• Registration Number: NCT05235607
• Lead Sponsor: Sichuan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-19
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-10
• Last Update Submitted: 2022-02-10
• Study First Posted: 2022-02-11
• Last Update Posted: 2022-02-11
• Study Start: 2022-03-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-12-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tumor antigen-sensitized vaccine and their sensitized T cells	Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administration	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0	3 months after the last administration of cells	Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0

Secondary Outcome Measures

Name	Time	Method
Number of participants with Overall survival as assessed by RECIST1.1	through study completion, an average of 1 year

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China