Targeted T-cell Therapy in Solid Tumors

August 30, 2019 updated by: Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.

Clinical Study of Targeted T-cell Therapy in Solid Tumors

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Early 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 Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518055
        • Recruiting
        • Department of oncology, the second people's hospital of shenzhen
        • Contact:

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:1. Age: 18~75 years old; 2. Patients with solid tumors still show progress after radiotherapy, chemotherapy and targeted therapy, with at least one measurable lesion; 3. No congenital autoimmune diseases or immunodeficiency diseases;' 4. At least one or more solid tumor targets of HER2, MUC1, CEA, EGFR and GPC3 were positive by immunohistochemical examination of tumor tissues; 5. No serious infectious diseases (hepatitis b, c, syphilis, AIDS); 6. Sign informed consent voluntarily. -

Exclusion Criteria:1. The researchers determined that the patient could not complete 6 courses of treatment.

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.

-

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: 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.
Other: 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.
Other Names:
  • decitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 1 year .
Overrall survival.The time of patient from randomization to death caused by any cause.
1 year .

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 1 year.
Progression-free survival.The time of patients from randomization to death caused by the progression of the tumor or any cause.
1 year.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
TTP
Time Frame: 1 year.
Time tumor progression.The time of patient from randomization to objective progress of the tumor.
1 year.
DCR
Time Frame: 1 year.
Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease.
1 year.
ORR
Time Frame: 1 year.
Objective response rate.The proportion of patients who had a best response rating of complete response and partial response.
1 year.
SRR
Time Frame: 1 year.
Symptom remission rate. The proportion of symptoms are alleviated in all evaluative cases.
1 year.

Collaborators and Investigators

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

Sponsor

Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.

Collaborators

Shenzhen Second People's Hospital

Investigators

  • Study Chair: Zeqiang Zhou, Doctor, Department of oncology, the second people's hospital of shenzhen
  • Study Director: Wenli Liang, Doctor, Department of oncology, the second people's hospital of shenzhen
  • Principal Investigator: Liang Xiao, Doctor, Department of oncology, the second people's hospital of shenzhen
  • Principal Investigator: Lin Lin, Doctor, Department of oncology, the second people's hospital of shenzhen
  • Principal Investigator: Meixiang Li, Doctor, Department of oncology, the second people's hospital of shenzhen

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 (Actual)

May 1, 2019

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

August 29, 2019

First Submitted That Met QC Criteria

August 30, 2019

First Posted (Actual)

September 3, 2019

Study Record Updates

Last Update Posted (Actual)

September 3, 2019

Last Update Submitted That Met QC Criteria

August 30, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BK2019.01

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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