Targeted T-cell Therapy in Solid Tumors

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: Malignant Solid Tumor
• Intervention / Treatment: Other: Targeted T-cell armed with bispecific antibody (Decitabine)

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

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518055
      • Recruiting
      • Department of oncology, the second people's hospital of shenzhen
      • Contact: Zhengcheng Li, Doctor; Phone Number: 6037 +86-0755-26912981; Email: lizhengcheng07@163.com

Participation Criteria

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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

Collaborators and Investigators

• 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

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: HER2; EGFR; GPC3; Targeted T-cell; CEA; MUC1
• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunologic Factors; Decitabine; Antibodies; Antibodies, Bispecific
• 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