Malignant Solid Tumor Clinical Trial
Official title:
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.
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. - |
Country | Name | City | State |
---|---|---|---|
China | Department of oncology, the second people's hospital of shenzhen | Shenzhen | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Benhealth Biopharmaceutical (Shenzhen) Co., Ltd. | Shenzhen Second People's Hospital |
China,
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. |
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