Clinical Trials /

A Clinical Research of CAR T Cells Targeting CEA Positive Cancer

NCT02349724

Description:

The main purpose of this research is to verify the safety of CEA targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.

Related Conditions:
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Gastric Carcinoma
  • Lung Carcinoma
  • Pancreatic Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Clinical Research of CAR T Cells Targeting CEA Positive Cancer
  • Official Title: A Clinical Research of Chimeric Antigen Receptor(CAR) T Cells Targeting CEA Positive Cancer

Clinical Trial IDs

  • ORG STUDY ID: TMMU-BTC-002
  • NCT ID: NCT02349724

Conditions

  • Lung Cancer
  • Colorectal Cancer
  • Gastric Cancer
  • Breast Cancer
  • Pancreatic Cancer

Interventions

DrugSynonymsArms
Anti-CEA-CAR TPancreatic cancer

Purpose

The main purpose of this research is to verify the safety of CEA targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.

Detailed Description

      Chimeric antigen receptor (CAR)-modified T cells have demonstrated great successes in
      treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell
      malignancies. But it has not yet been fully explored in solid tumors. The carcino-embryonic
      antigen(CEA) is widely expressed in cancers like gastric cancer, lung cancer, pancreatic
      cancer, breast cancer and colorectal cancer. To confirm if CAR T cells still function in
      solid tumors, we have developed anti-CEA CAR-modified T cells. Preclinical studies have
      demonstrated effective killing of CEA target cells. In this study, the CEA CARs, will be
      evaluated in CEA positive gastric cancer, lung cancer, pancreatic cancer, breast cancer and
      colorectal cancer patients. The primary goal is to confirm its adverse effects including
      cytokine storm response and any other adverse effects. In addition, tumor targeting and
      disease status after treatment will also be evaluated.
    

Trial Arms

NameTypeDescriptionInterventions
Pancreatic cancerOtherPancreatic cancer treated with Anti-CEA-CAR T.
    Lung cancerOtherLung cancer treated with T cells modified with Anti-CEA-CAR T.
      Gastric cancerOtherGastric cancer treated with T cells modified with Anti-CEA-CAR T.
        Breast cancerOtherBreast cancer treated with T cells modified with Anti-CEA-CAR T.
          Colorectal cancerOtherColorectal cancer treated with T cells modified with Anti-CEA-CAR T.

            Eligibility Criteria

                    Inclusion Criteria:
            
                      1. Relapsed or refractory CEA positive lung cancer, pancreatic cancer, gastric cancer,
                         breast cancer and colorectal cancer.
            
                      2. KPS>60.
            
                      3. Life expectancy>3 months.
            
                      4. Gender unlimited, age from 18 years to 80 years.
            
                      5. Disease progresses but reserves reaction to recent treatments.
            
                      6. Patients who have failed at least one line of a standard treatment.
            
                      7. No serious mental disorder.
            
                      8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate
                         pulmonary function as indicated by room air oxygen saturation of >94%, and adequate
                         renal function(Cr≤133umol/L).
            
                      9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
            
                     10. No other tumors.
            
                     11. Patients volunteer to participate in the research.
            
                    Exclusion Criteria:
            
                      1. KPS<50.
            
                      2. Patients are allergic to cytokines.
            
                      3. MODS.
            
                      4. Uncontrolled active infection.
            
                      5. Acute or chronic GVHD.
            
                      6. Treated with T cell inhibitor.
            
                      7. Pregnancy and nursing females.
            
                      8. HIV affected.
            
                      9. Other situations we think improper for the research.
                  
            Maximum Eligible Age:80 Years
            Minimum Eligible Age:18 Years
            Eligible Gender:All
            Healthy Volunteers:No

            Primary Outcome Measures

            Measure:Adverse events of each patient.
            Time Frame:3 years
            Safety Issue:
            Description:Determine the toxicity profile of the CEA targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.

            Secondary Outcome Measures

            Measure:Survival time of Anti-CEA CAR T cells in vivo.
            Time Frame:3 years
            Safety Issue:
            Description:To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
            Measure:Efficacy of anti-CEA CAR T cells to confirm the ability of CAR T cells to kill CEA positive cancer cells
            Time Frame:12 weeks
            Safety Issue:
            Description:
            Measure:Maximum tolerated dose (MTD) of CEA targeted CAR T cells.
            Time Frame:4 weeks
            Safety Issue:
            Description:To confirm the maximum tolerated dose of CEA targeted CAR T cells.

            Details

            Phase:Phase 1
            Primary Purpose:Interventional
            Overall Status:Recruiting
            Lead Sponsor:Southwest Hospital, China

            Trial Keywords

            • CEA
            • CAR T

            Last Updated

            April 24, 2017