Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors
Phase 1
- Conditions
- Bladder CancerCarcinomaColorectal CancerMelanoma
- 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
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
- 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
West China Hospital🇨🇳Chengdu, Sichuan, China