NCT04430595

Brief Summary

The purpose of this study is to assess the feasibility, safety and efficacy of multiple 4th generation CAR-T cells targeting Her2, GD2, and CD44v6 surface antigen in breast cancer. Another goal of the study is to learn more about the activities of the multi-CAR T cells and their persistency in the patients.

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
100

participants targeted

Target at P75+ for phase_1 breast-cancer

Timeline
Completed

Started Jun 2020

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

June 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

3 years

First QC Date

June 9, 2020

Last Update Submit

June 10, 2020

Conditions

Breast Cancer

Keywords

CARTadoptive T cell transferHer2GD2CD44V6

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse events.

    Determine the toxicity profile the multi-4SCAR-T cells with Common Toxicity Criteria for Adverse Effects version 4.0

    3 year

Secondary Outcomes (3)

  • Anti-tumor effects

    3 year

  • The expansion and persistence of CAR-T cells

    3 months

  • Survival time of the patients

    3 year

Study Arms (1)

Multiple 4SCAR T cells to treat breast cancer

EXPERIMENTAL

Multiple 4SCAR T cells to treat breast cancer

Biological: 4SCAR T cells

Interventions

4SCAR T cellsBIOLOGICAL

Infusion of 4SCAR-GD2, -Her2 and -CD44v6 CAR-T cells

Multiple 4SCAR T cells to treat breast cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with stage III, IV or relapsed breast cancer confirmed by histology and biopsy.
  • Age: ≥ 18 years and ≤ 75 years.
  • weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy.
  • Side effects of chemotherapy have subsided.
  • The target antigens GD2, CD44v6, or Her2 is expressed in malignancy tissues by immuno-histochemical or flow cytometry.
  • Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
  • Expected survival ≥ 12 weeks.
  • Initial hematopoietic reconstitution with neutrophils (ANC) ≥ 1×10\^6/L; platelet (PLT) ≥ 1×10\^8/L.
  • Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with serum creatinine ≤ 2×ULN; serum bilirubin ≤ 3×ULN; AST/ALT ≤ 2.5×ULN.
  • Oxygen saturation ≥ 90%.
  • Written, informed consent obtained prior to any study-specific procedures.

You may not qualify if:

  • Airway obstruction caused by tumor.
  • History of epilepsy or other central nervous system diseases.
  • Patients who require systemic corticosteroid or other immunosuppressive therapy.
  • History of prolonged or serious heart disease during QT.
  • Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
  • Inadequate liver and renal function with serum creatinine \> 1.5 mg/dl; serum (total) bilirubin \> 2.0 mg/dl; AST \& ALT \> 3 x ULN.
  • Pregnant or lactating females.
  • Serious active infection during screening.
  • Active HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) infection or uncontrolled infection.
  • Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Seventh Affilliated Hospital, Sun Yat-Sen University

Shenzhen, Guangdong, 518107, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Lung-Ji Chang, PhD

CONTACT

+86(755)8672 5195c@szgimi.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 12, 2020

Study Start

June 1, 2020

Primary Completion

May 31, 2023

Study Completion

December 31, 2023

Last Updated

June 12, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)