NCT02349724

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P75+ for phase_1 lung-cancer

Timeline
Completed

Started Dec 2014

Typical duration for phase_1 lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 25, 2017

Status Verified

March 1, 2016

Enrollment Period

4 years

First QC Date

January 25, 2015

Last Update Submit

April 24, 2017

Conditions

Lung CancerColorectal CancerGastric CancerBreast CancerPancreatic Cancer

Keywords

CEACAR T

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Survival time of Anti-CEA CAR T cells in vivo.

    3 years

  • Efficacy of anti-CEA CAR T cells to confirm the ability of CAR T cells to kill CEA positive cancer cells

    12 weeks

  • Maximum tolerated dose (MTD) of CEA targeted CAR T cells.

    4 weeks

Study Arms (5)

Pancreatic cancer

OTHER

Pancreatic cancer treated with Anti-CEA-CAR T.

Biological: Anti-CEA-CAR T

Lung cancer

OTHER

Lung cancer treated with T cells modified with Anti-CEA-CAR T.

Biological: Anti-CEA-CAR T

Gastric cancer

OTHER

Gastric cancer treated with T cells modified with Anti-CEA-CAR T.

Biological: Anti-CEA-CAR T

Breast cancer

OTHER

Breast cancer treated with T cells modified with Anti-CEA-CAR T.

Biological: Anti-CEA-CAR T

Colorectal cancer

OTHER

Colorectal cancer treated with T cells modified with Anti-CEA-CAR T.

Biological: Anti-CEA-CAR T

Interventions

Anti-CEA-CAR TBIOLOGICAL

T cells modified with CEA targeted chimeric antigen receptor.

Breast cancerColorectal cancerGastric cancerLung cancerPancreatic cancer

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Relapsed or refractory CEA positive lung cancer, pancreatic cancer, gastric cancer, breast cancer and colorectal cancer.
  • KPS\>60.
  • Life expectancy\>3 months.
  • Gender unlimited, age from 18 years to 80 years.
  • Disease progresses but reserves reaction to recent treatments.
  • Patients who have failed at least one line of a standard treatment.
  • No serious mental disorder.
  • 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).
  • No other serious diseases(autoimmune disease, immunodeficiency etc.).
  • No other tumors.
  • Patients volunteer to participate in the research.

You may not qualify if:

  • KPS\<50.
  • Patients are allergic to cytokines.
  • MODS.
  • Uncontrolled active infection.
  • Acute or chronic GVHD.
  • Treated with T cell inhibitor.
  • Pregnancy and nursing females.
  • HIV affected.
  • Other situations we think improper for the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Hospital of Third Millitary Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsColorectal NeoplasmsStomach NeoplasmsBreast NeoplasmsPancreatic Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesStomach DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Cheng Qian, MD, PhD

    Southwest Hospital, China

    STUDY CHAIR

Central Study Contacts

Cheng Qian, MD, PhD

CONTACT

0086-023-68765461cqian8634@gmail.com

Zhi Yang, PhD

CONTACT

0086-13206140093Lystch@outlook.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher of Biotherpy Center

Study Record Dates

First Submitted

January 25, 2015

First Posted

January 29, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

April 25, 2017

Record last verified: 2016-03

Locations

CN(1)