Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors

NCT ID: NCT05235607

Last Updated: 2022-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-12-02

Brief Summary

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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

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Conditions

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Carcinoma Melanoma Bladder Cancer Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

subcutaneous administration

Interventions

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

subcutaneous administration

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sichuan University

OTHER

Sponsor Role lead

Responsible Party

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Zhen-Yu Ding

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ji-Yan Liu

Role: PRINCIPAL_INVESTIGATOR

Sichuan University

Locations

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West China Hospital

Chengdu, Sichuan, China

Site Status

Countries

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China

Central Contacts

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Ji-Yan Liu, Prof

Role: CONTACT

028-85422039

Other Identifiers

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PITTN2021

Identifier Type: -

Identifier Source: org_study_id

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