Clinical trial NCT03013712: A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer
Official title: A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Colon Cancer
Esophageal Carcinoma
Pancreatic Cancer
Prostate Cancer
Gastric Cancer
Hepatic Carcinoma
Lead sponsor: First Affiliated Hospital of Chengdu Medical College
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
timeFrame: up to 24 months
Secondary outcomes:
measure: Survival time of anti-EpCAM CAR T cells in vivo
timeFrame: up to 24 months
measure: Anti-tumor efficacy of CAR-T therapy by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Chendu
country: China
facility: IEC of Chengdu Medical College
Study officials:
affiliation: First Affiliated Hospital of Chengdu Medical College
name: Xiao-an Li, PhD
role: STUDY_CHAIR
References: