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Targeted T-cell Therapy in Solid Tumors

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ClinicalTrials.gov Identifier: NCT04076137
Recruitment Status : Recruiting
First Posted : September 2, 2019
Last Update Posted : September 2, 2019
Sponsor:
Collaborator:
Shenzhen Second People's Hospital
Information provided by (Responsible Party):
Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malignant Solid Tumor Other: Targeted T-cell armed with bispecific antibody (Decitabine) Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Masking Description: targeted activated T-cell
Primary Purpose: Treatment
Official Title: Clinical Study of Targeted T-cell Therapy in Solid Tumors
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


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 Name: decitabine




Primary Outcome Measures :
  1. OS [ Time Frame: 1 year . ]
    Overrall survival.The time of patient from randomization to death caused by any cause.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. TTP [ Time Frame: 1 year. ]
    Time tumor progression.The time of patient from randomization to objective progress of the tumor.

  2. 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.

  3. ORR [ Time Frame: 1 year. ]
    Objective response rate.The proportion of patients who had a best response rating of complete response and partial response.

  4. SRR [ Time Frame: 1 year. ]
    Symptom remission rate. The proportion of symptoms are alleviated in all evaluative cases.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04076137


Contacts
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Contact: Zhengzheng Li, Doctor 0755-26912981 ext 6037 lizhengcheng07@163.com
Contact: Jiana Fan, bachelar 0755-26912981 ext 6002 1244322047@qq.com

Locations
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China, Guangdong
Department of oncology, the second people's hospital of shenzhen Recruiting
Shenzhen, Guangdong, China, 518055
Contact: Zhengcheng Li, Doctor    +86-0755-26912981 ext 6037    lizhengcheng07@163.com   
Sponsors and Collaborators
Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.
Shenzhen Second People's Hospital
Investigators
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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

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Responsible Party: Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.
ClinicalTrials.gov Identifier: NCT04076137     History of Changes
Other Study ID Numbers: BK2019.01
First Posted: September 2, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.:
Targeted T-cell
HER2
MUC1
CEA
EGFR
GPC3
Additional relevant MeSH terms:
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Neoplasms
Decitabine
Antibodies
Immunoglobulins
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors