Targeted T-cell Therapy in Solid Tumors

Malignant Solid Tumor Clinical Trial

Official title:

Clinical Study of Targeted T-cell Therapy in Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04076137
• Other study ID #: BK2019.01
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: August 2019
• Source: Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.
• Contact: Zhengzheng Li, Doctor
• Phone: 0755-26912981
• Email: lizhengcheng07[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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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Related Conditions & MeSH terms

• Malignant Solid Tumor
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Department of oncology, the second people's hospital of shenzhen	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.	Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TTP	Time tumor progression.The time of patient from randomization to objective progress of the tumor.	1 year.
Other	DCR	Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease.	1 year.
Other	ORR	Objective response rate.The proportion of patients who had a best response rating of complete response and partial response.	1 year.
Other	SRR	Symptom remission rate. The proportion of symptoms are alleviated in all evaluative cases.	1 year.
Primary	OS	Overrall survival.The time of patient from randomization to death caused by any cause.	1 year .
Secondary	PFS	Progression-free survival.The time of patients from randomization to death caused by the progression of the tumor or any cause.	1 year.