Targeted T-cell Therapy in Solid Tumors

Early Phase 1

• Conditions: Malignant Solid Tumor
• Interventions: Other: Targeted T-cell armed with bispecific antibody (Decitabine)

• Registration Number: NCT04076137
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-05-01
• Status Verified: 2019-08
• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-08-30
• Last Update Submitted: 2019-08-30
• Study First Posted: 2019-09-03
• Last Update Posted: 2019-09-03
• Primary Completion: 2020-05-01
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Targeted T-cell	Targeted T-cell armed with bispecific antibody (Decitabine)	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.

Primary Outcome Measures

Name	Time	Method
OS	1 year .	Overrall survival.The time of patient from randomization to death caused by any cause.

Secondary Outcome Measures

Name	Time	Method
PFS	1 year.	Progression-free survival.The time of patients from randomization to death caused by the progression of the tumor or any cause.

Trial Locations

Locations (1)

Department of oncology, the second people's hospital of shenzhen; 🇨🇳 Shenzhen, Guangdong, China