Clinical trial NCT04076137: Targeted T-cell Therapy in Solid Tumors
Official title: Clinical Study of Targeted T-cell Therapy in Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Malignant Solid Tumor
Keywords: Targeted T-cell
HER2
MUC1
CEA
EGFR
GPC3
Lead sponsor: Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shenzhen Second People's Hospital
First posted: 2019-09-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility 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.

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Primary outcomes:
measure: OS
timeFrame: 1 year .
Secondary outcomes:
measure: PFS
timeFrame: 1 year.
Other outcomes:
measure: TTP
timeFrame: 1 year.
measure: DCR
timeFrame: 1 year.
measure: ORR
timeFrame: 1 year.
measure: SRR
timeFrame: 1 year.
Locations:
city: Shenzhen
country: China
facility: Department of oncology, the second people's hospital of shenzhen
state: Guangdong
Study officials:
affiliation: Department of oncology, the second people's hospital of shenzhen
name: Zeqiang Zhou, Doctor
role: STUDY_CHAIR
affiliation: Department of oncology, the second people's hospital of shenzhen
name: Wenli Liang, Doctor
role: STUDY_DIRECTOR
affiliation: Department of oncology, the second people's hospital of shenzhen
name: Liang Xiao, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of oncology, the second people's hospital of shenzhen
name: Lin Lin, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of oncology, the second people's hospital of shenzhen
name: Meixiang Li, Doctor
role: PRINCIPAL_INVESTIGATOR
References: