Colon Cancer, Esophageal Carcinoma, Gastric Cancer, Hepatic Carcinoma, Pancreatic Cancer, Prostate Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of EpCAM-specific CAR T Cells infusion for EpCAM positive Cancer.
Detailed description
This study is being conducted to evaluate the safety and efficacy of Chimeric antigen receptor (CAR) T cells targeting EpCAM in treating patients with EpCAM positive cancer. In the research, the investigators design a novel CAR consists of a EpCAM targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. The infusion dose is (1-10)×106 EpCAM-CAR positive T cells/kg, and the specific cells numbers depends on the situation of individual CAR-T cells preparation. The way of infusion is vascular interventional mediated or endoscopy, and the cells perfusion process would lasts 15min to 30min, and the specific time depends on patent's tumor-burdened state. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
Interventions
BIOLOGICALCAR-T cell immunotherapy
This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen.
Sponsors
First Affiliated Hospital of Chengdu Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Relapsed or refractory EpCAM positive cancer. 2. KPS \> 60. 3. Life expectancy\>3 months. 4. Gender unlimited, age from 18 years to 80 years. 5. Assessable lesions with a minimum size of 10mm by CT scan or MRI. 6. Acceptable organ function Hematology: * Absolute neutrophil count greater than 800/mm\^3 without the support of filgrastim. * White blood cell (WBC) (\> 2000/mm\^3). * Platelet count greater than 50,000/mm\^3. * Hemoglobin greater than 9.0 g/dl. 7. No other serious diseases(autoimmune disease, immunodeficiency etc.). 8. Adequate cardiac function (LVEF ≥ 40%). 9. No other tumors. 10. Patients volunteer to participate in the research.
Exclusion criteria
1. Allergic to cytokines. 2. Uncontrolled active infection. 3. Acute or chronic GVHD. 4. MODS. 5. Treated with T cell inhibitor. 6. HIV affected. 7. Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0 | up to 24 months | Observe and handle the toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival time of anti-EpCAM CAR T cells in vivo | up to 24 months | Detect the existence of CAR-T cells in the blood of participants through flow cytometry |
| Anti-tumor efficacy of CAR-T therapy by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 | up to 24 months | Anti-tumor efficacy of CAR-T therapy for patients with EpCAM positive cancers was assessed by RECIST v1.1 |
Countries
China
Contacts
Primary ContactYan Zhou, PhD
Outcome results
None listed