Targeted T-cell Therapy in Solid Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Early Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Targeted T-cell 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. |
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- OS [1 year .]
Overrall survival.The time of patient from randomization to death caused by any cause.
Secondary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
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.
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Patients with t-cell lymphoma. 3. Pregnant or lactating female patients, or those who do not want to use contraception during the trial.
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Allergic to both CT and MRI contrast agents and unable to conduct imaging evaluation.
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Other patients in the treated group who were considered as unfit for cell therapy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of oncology, the second people's hospital of shenzhen | Shenzhen | Guangdong | China | 518055 |
Sponsors and Collaborators
- Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.
- Shenzhen Second People's Hospital
Investigators
- Study Chair: Zeqiang Zhou, Doctor, Department of oncology, the second people's hospital of shenzhen
- Study Director: Wenli Liang, Doctor, Department of oncology, the second people's hospital of shenzhen
- Principal Investigator: Liang Xiao, Doctor, Department of oncology, the second people's hospital of shenzhen
- Principal Investigator: Lin Lin, Doctor, Department of oncology, the second people's hospital of shenzhen
- Principal Investigator: Meixiang Li, Doctor, Department of oncology, the second people's hospital of shenzhen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BK2019.01