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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lung Cancer Colorectal Cancer Gastric Cancer Breast Cancer Pancreatic Cancer Biological: Anti-CEA-CAR T Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Research of Chimeric Antigen Receptor(CAR) T Cells Targeting CEA Positive Cancer
Study Start Date : December 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

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Arms and Interventions
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Arm Intervention/treatment
Pancreatic cancer
Pancreatic cancer treated with Anti-CEA-CAR T.
 Biological: Anti-CEA-CAR T
T cells modified with CEA targeted chimeric antigen receptor.
Lung cancer
Lung cancer treated with T cells modified with Anti-CEA-CAR T.
 Biological: Anti-CEA-CAR T
T cells modified with CEA targeted chimeric antigen receptor.
Gastric cancer
Gastric cancer treated with T cells modified with Anti-CEA-CAR T.
 Biological: Anti-CEA-CAR T
T cells modified with CEA targeted chimeric antigen receptor.
Breast cancer
Breast cancer treated with T cells modified with Anti-CEA-CAR T.
 Biological: Anti-CEA-CAR T
T cells modified with CEA targeted chimeric antigen receptor.
Colorectal cancer
Colorectal cancer treated with T cells modified with Anti-CEA-CAR T.
 Biological: Anti-CEA-CAR T
T cells modified with CEA targeted chimeric antigen receptor.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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 ]
  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02349724


Contacts
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Contact: Cheng Qian, MD, PhD 0086-023-68765461 cqian8634@gmail.com
Contact: Zhi Yang, PhD 0086-13206140093 Lystch@outlook.com

Locations
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China, Chongqing
Southwest Hospital of Third Millitary Medical University Recruiting
Chongqing, Chongqing, China, 400000
Contact: Cheng Qian, PhD    008615086883400    cqian8634@gmail.com   
Contact: Zhi Yang, PhD    008613206140093      
Principal Investigator: Cheng Qian, PhD         
Sponsors and Collaborators
Southwest Hospital, China
Investigators
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Study Chair: Cheng Qian, MD, PhD Southwest Hospital, China
More Information
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Responsible Party: Zhi Yang, Researcher of Biotherpy Center, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT02349724    
Other Study ID Numbers: TMMU-BTC-002
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: March 2016
Keywords provided by Zhi Yang, Southwest Hospital, China:
CEA
CAR T