NCT05235607

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2023

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

December 19, 2021

Last Update Submit

February 10, 2022

Conditions

CarcinomaMelanomaBladder CancerColorectal Cancer

Keywords

MelanomaBladder CancerColorectal Cancertumor neo-antigen DC vaccinesafetyclinical efficacy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of participants with Overall survival as assessed by RECIST1.1

    through study completion, an average of 1 year

Study Arms (1)

Tumor antigen-sensitized vaccine and their sensitized T cells

EXPERIMENTAL

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

Interventions

Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administrationBIOLOGICAL

subcutaneous administration

Tumor antigen-sensitized vaccine and their sensitized T cells

Eligibility Criteria

Age18 Years - 75 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • Tumor emergencies;
  • Abnormal coagulation function;
  • Contagious diseases, such as HIV, HBV, HCV infection;
  • Mental disorders;
  • Concomitant tumors;
  • Immunological co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

CarcinomaMelanomaUrinary Bladder NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Ji-Yan Liu

    Sichuan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji-Yan Liu, Prof

CONTACT

028-85422039liujiyan1972@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 19, 2021

First Posted

February 11, 2022

Study Start

March 1, 2022

Primary Completion

June 1, 2023

Study Completion

December 2, 2023

Last Updated

February 11, 2022

Record last verified: 2022-02

Locations

CN(1)