A Clinical Research of CAR T Cells Targeting CEA Positive Cancer

Breast Cancer Clinical Trial

Official title:

A Clinical Research of Chimeric Antigen Receptor(CAR) T Cells Targeting CEA Positive Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02349724
• Other study ID #: TMMU-BTC-002
• Status: Recruiting
• Phase: Phase 1
• First received: January 25, 2015
• Last updated: April 24, 2017
• Start date: December 2014
• Est. completion date: December 2019

Study information

• Verified date: March 2016
• Source: Southwest Hospital, China
• Contact: Cheng Qian, MD, PhD
• Phone: 0086-023-68765461
• Email: cqian8634[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Gastric Cancer
• Lung Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Stomach Neoplasms

Intervention

Biological:
• Anti-CEA-CAR T
T cells modified with CEA targeted chimeric antigen receptor.

Locations

Country	Name	City	State
China	Southwest Hospital of Third Millitary Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events of each patient.	Determine the toxicity profile of the CEA targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.	3 years
Secondary	Survival time of Anti-CEA CAR T cells in vivo.	To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.	3 years
Secondary	Efficacy of anti-CEA CAR T cells to confirm the ability of CAR T cells to kill CEA positive cancer cells		12 weeks
Secondary	Maximum tolerated dose (MTD) of CEA targeted CAR T cells.	To confirm the maximum tolerated dose of CEA targeted CAR T cells.	4 weeks