A Clinical Research of CAR T Cells Targeting CEA Positive Cancer

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

Tracking Information

• First Submitted Date: January 25, 2015
• First Posted Date: January 29, 2015
• Last Update Posted Date: April 25, 2017
• Study Start Date: December 2014
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

Biological: Anti-CEA-CAR T

T cells modified with CEA targeted chimeric antigen receptor.

Study Arms

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 28, 2015): 75
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2019
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02349724
• Other Study ID Numbers: TMMU-BTC-002
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Zhi Yang, Southwest Hospital, China
• Study Sponsor: Southwest Hospital, China
• Collaborators: Not Provided

Investigators

• Study Chair: Cheng Qian, MD, PhD; Southwest Hospital, China

• PRS Account: Southwest Hospital, China
• Verification Date: March 2016