Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors

February 10, 2022 updated by: Zhen-Yu Ding, Sichuan University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • West China Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional 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

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
subcutaneous administration

What is the study measuring?

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
Time Frame: 3 months after the last administration of cells
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
Time Frame
Number of participants with Overall survival as assessed by RECIST1.1
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan University

Investigators

  • Principal Investigator: Ji-Yan Liu, Sichuan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 2, 2023

Study Registration Dates

First Submitted

December 19, 2021

First Submitted That Met QC Criteria

February 10, 2022

First Posted (Actual)

February 11, 2022

Study Record Updates

Last Update Posted (Actual)

February 11, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PITTN2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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