Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors

Colorectal Cancer Clinical Trial

Official title:

Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05235607
• Other study ID #: PITTN2021
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 1, 2022
• Est. completion date: December 2, 2023

Study information

• Verified date: February 2022
• Source: Sichuan University
• Contact: Ji-Yan Liu, Prof
• Phone: 028-85422039
• Email: liujiyan1972[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma
• Colorectal Cancer
• Colorectal Neoplasms
• Melanoma
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with Overall survival as assessed by RECIST1.1		through study completion, an average of 1 year