Targeted T-cell Therapy in Solid Tumors

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

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-05-01

Brief Summary

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This is a single-center, open, single-arm controlled prospective clinical trial of patients with solid tumors treated with targeted activation of T cells through intravenous infusion.The purpose of this study was to evaluate the clinical efficacy and safety of targeted activated T cells in the treatment of solid tumors.

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Detailed Description

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In China, malignant tumors have become the leading cause of death for urban and rural residents, with solid tumors accounting for 77 percent.Immunotherapy is considered one of the most promising ways to fight cancer.This study is a single-center, open, single-arm controlled clinical trial (after intravenous infusion of targeted T cells, compare the changes of self-lesion). The essence of this study is to collect immune cells to the surrounding of tumor cells, so that immune cells can kill tumor cells at close range.The researchers plan to enroll 10 patients with solid tumors and follow them up to the end of the study after completing 9 courses of treatment.The results of this study were statistically analyzed using RECIST1.1 records.

Conditions

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Malignant Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a single-center, open, single-arm controlled prospective clinical study to investigate the efficacy and safety of targeted T-cell therapy in solid tumors.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

targeted activated T-cell

Study Groups

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Targeted T-cell

This study is a pre-phase I immunotherapy trial in 10 people with malignant solid tumor consisting of 9 infusions of bispecific antibody armed anti-CD3-Actibated T cells(ATC) to determine safety, maximum tolerated dose (MTD), technical feasibility, immune responses.

Group Type EXPERIMENTAL

Targeted T-cell armed with bispecific antibody (Decitabine)

Intervention Type OTHER

In this study, 10 patients eligible for the study were clinically screened for intravenous infusion of targeted activated T cells,every participant has a unique identification number and emergency letter which have the information of group.

Interventions

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Targeted T-cell armed with bispecific antibody (Decitabine)

In this study, 10 patients eligible for the study were clinically screened for intravenous infusion of targeted activated T cells,every participant has a unique identification number and emergency letter which have the information of group.

Intervention Type OTHER

Other Intervention Names

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decitabine

Eligibility Criteria

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Exclusion Criteria

2\. Patients with t-cell lymphoma. 3. Pregnant or lactating female patients, or those who do not want to use contraception during the trial.

4\. Allergic to both CT and MRI contrast agents and unable to conduct imaging evaluation.

5\. Other patients in the treated group who were considered as unfit for cell therapy.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR