NCT02713984

Brief Summary

Chimeric antigen receptor T cells (CAR-T) therapy has not yet been fully explored in solid tumors. Human epidermal growth factor receptor-2(HER2) is widely expressed in cancers. Investigators have developed anti-HER2 CAR-modified T cells and validated the efficiency targeting HER2-positive cancer in preclinical studies. This study is aimed to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, CAR-T cells persistence, tumor elimination and disease status after treatment will be evaluated.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

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

March 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

3.3 years

First QC Date

March 12, 2016

Last Update Submit

March 17, 2020

Conditions

Breast CancerOvarian CancerLung CancerGastric CancerColorectal CancerGliomaPancreatic Cancer

Keywords

HER2 CAR-Tsafetyefficiencyrefractory and relapsed cancer

Outcome Measures

Primary Outcomes (1)

  • Determine the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.

    Observe and handle the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.

    3 years

Secondary Outcomes (3)

  • Survival time of Anti-HER2 CAR T cells in vivo.

    1 year

  • Efficacy of anti-HER2 CAR T cells to confirm the ability of CAR T cells to eliminate HER2 positive cancer cells

    12 weeks

  • Maximum tolerated dose (MTD) of HER2 targeted CAR T cells

    4 weeks

Study Arms (1)

HER2 positive cancers

EXPERIMENTAL

Patients with relapsed and refractory cancer of HER2 expression will be treated with anti-HER2 CAR-T cells

Biological: Anti-HER2 CAR-T

Interventions

Anti-HER2 CAR-TBIOLOGICAL

HER-2-targeting CAR-T cells infusion in HER2 positive cancers

HER2 positive cancers

Eligibility Criteria

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

You may qualify if:

  • Relapsed or refractory HER2 positive cancer.
  • KPS\>60.
  • Life expectancy\>3 months.
  • Gender unlimited, age from 18 years to 80 years.
  • Assessable lesions with a minimum size of 10mm by CT scan or MRI.
  • Acceptable organ function
  • Hematology:
  • Absolute neutrophil count greater than 800/mm\^3 without the support of filgrastim.
  • White blood cell (WBC) (\> 2000/mm\^3).
  • Platelet count greater than 50,000/mm\^3.
  • Hemoglobin greater than 9.0 g/dl.
  • Chemistry:
  • Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 3 times the upper limit of normal (patients without liver metastasis) or 6 times the upper limit of normal (patients with liver metastasis).
  • Serum creatinine less or equal to 3 times the upper limit of normal
  • Total bilirubin less than or equal to 3 times the upper limit of normal.
  • +4 more criteria

You may not qualify if:

  • Allergic to cytokines.
  • Uncontrolled active infection.
  • Acute or chronic GVHD.
  • MODS.
  • Treated with T cell inhibitor.
  • HIV affected.
  • Other situations 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

Location

MeSH Terms

Conditions

Breast NeoplasmsOvarian NeoplasmsLung NeoplasmsStomach NeoplasmsColorectal NeoplasmsGliomaPancreatic NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissuePancreatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cheng Qian, MD,PhD

    Southwest Hospital, China

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

March 12, 2016

First Posted

March 21, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

March 19, 2020

Record last verified: 2020-03

Locations

CN(1)