Malignant Solid Tumor
Conditions
Keywords
Targeted T-cell, HER2, MUC1, CEA, EGFR, GPC3
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.
Interventions
OTHERTargeted 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.
Sponsors
Shenzhen Second People's Hospital
Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
targeted activated T-cell
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OS | 1 year . | Overrall survival.The time of patient from randomization to death caused by any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 1 year. | Progression-free survival.The time of patients from randomization to death caused by the progression of the tumor or any cause. |
Other
| Measure | Time frame | Description |
|---|---|---|
| TTP | 1 year. | Time tumor progression.The time of patient from randomization to objective progress of the tumor. |
| DCR | 1 year. | Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease. |
| ORR | 1 year. | Objective response rate.The proportion of patients who had a best response rating of complete response and partial response. |
| SRR | 1 year. | Symptom remission rate. The proportion of symptoms are alleviated in all evaluative cases. |
Countries
China
Contacts
Primary ContactZhengzheng Li, Doctor
Backup ContactJiana Fan, bachelar
Outcome results
None listed