Description:
The purpose of this study is to evaluate the safety and efficacy of EpCAM-specific CAR T
Cells infusion for EpCAM positive Cancer.
Title
- Brief Title: A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer
- Official Title: A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer
Clinical Trial IDs
- ORG STUDY ID:
CARTEPC-001
- NCT ID:
NCT03013712
Conditions
- Colon Cancer
- Esophageal Carcinoma
- Pancreatic Cancer
- Prostate Cancer
- Gastric Cancer
- Hepatic Carcinoma
Interventions
| Drug | Synonyms | Arms |
|---|
| CAR-T cell immunotherapy | | CAR-T cell immunotherapy |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| 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 Criteria
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.
| Maximum Eligible Age: | 80 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0 |
| Time Frame: | up to 24 months |
| Safety Issue: | |
| Description: | 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 Outcome Measures
| Measure: | Survival time of anti-EpCAM CAR T cells in vivo |
| Time Frame: | up to 24 months |
| Safety Issue: | |
| Description: | Detect the existence of CAR-T cells in the blood of participants through flow cytometry |
| Measure: | Anti-tumor efficacy of CAR-T therapy by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 |
| Time Frame: | up to 24 months |
| Safety Issue: | |
| Description: | Anti-tumor efficacy of CAR-T therapy for patients with EpCAM positive cancers was assessed by RECIST v1.1 |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Unknown status |
| Lead Sponsor: | First Affiliated Hospital of Chengdu Medical College |
Last Updated
January 6, 2017
