Clinical trialPhase 1 / Phase 2Unknown
A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer
- Outcome
- Outcome unknown
- Cell product
- CAR-T cells
A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer
- Target antigen
- EpCAM
A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer
- Phase
- Phase 1 / Phase 2
- Status
- Unknown
- Study type
- Interventional
- Start
- January 2017
- Listed end
- December 2020
- Enrollment
- 60 participants
- Sites
- 1
- Primary outcomes
- Toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 6 January 2017
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Intervention public domain (ClinicalTrials.gov)
Biological: CAR-T cell immunotherapy. This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen.
Arm public domain (ClinicalTrials.gov)
CAR-T cell immunotherapy (experimental): Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen by infusion.
Eligibility public domain (ClinicalTrials.gov)
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.