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A Clinical Research of CAR T Cells Targeting CEA Positive Cancer

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ClinicalTrials.gov Identifier: NCT02349724
Recruitment Status : Unknown
Verified March 2016 by Zhi Yang, Southwest Hospital, China.
Recruitment status was:  Recruiting
First Posted : January 29, 2015
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Zhi Yang, Southwest Hospital, China

Tracking Information
First Submitted Date  ICMJE January 25, 2015
First Posted Date  ICMJE January 29, 2015
Last Update Posted Date April 25, 2017
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
Adverse events of each patient. [ Time Frame: 3 years ]
Determine the toxicity profile of the CEA targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
  • Survival time of Anti-CEA CAR T cells in vivo. [ Time Frame: 3 years ]
    To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
  • 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 ]
  • Maximum tolerated dose (MTD) of CEA targeted CAR T cells. [ Time Frame: 4 weeks ]
    To confirm the maximum tolerated dose of CEA targeted CAR T cells.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Research of CAR T Cells Targeting CEA Positive Cancer
Official Title  ICMJE A Clinical Research of Chimeric Antigen Receptor(CAR) T Cells Targeting CEA Positive Cancer
Brief Summary 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Cancer
  • Colorectal Cancer
  • Gastric Cancer
  • Breast Cancer
  • Pancreatic Cancer
Intervention  ICMJE Biological: Anti-CEA-CAR T
T cells modified with CEA targeted chimeric antigen receptor.
Study Arms  ICMJE
  • Pancreatic cancer
    Pancreatic cancer treated with Anti-CEA-CAR T.
    Intervention: Biological: Anti-CEA-CAR T
  • Lung cancer
    Lung cancer treated with T cells modified with Anti-CEA-CAR T.
    Intervention: Biological: Anti-CEA-CAR T
  • Gastric cancer
    Gastric cancer treated with T cells modified with Anti-CEA-CAR T.
    Intervention: Biological: Anti-CEA-CAR T
  • Breast cancer
    Breast cancer treated with T cells modified with Anti-CEA-CAR T.
    Intervention: Biological: Anti-CEA-CAR T
  • Colorectal cancer
    Colorectal cancer treated with T cells modified with Anti-CEA-CAR T.
    Intervention: Biological: Anti-CEA-CAR T
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 28, 2015)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02349724
Other Study ID Numbers  ICMJE TMMU-BTC-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhi Yang, Southwest Hospital, China
Study Sponsor  ICMJE Southwest Hospital, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Cheng Qian, MD, PhD Southwest Hospital, China
PRS Account Southwest Hospital, China
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP