Chimeric Antigen Receptor T-Cell Therapy for HER2-positive Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
HER2-positive Breast Cancer+4 MoreChimeric Antigen Receptor T-Cell Therapy - Biological
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer treatment that involves delivering genetically-modified T cells into the brain. The goal is to find the best dose and to assess side effects.

Eligible Conditions
  • HER2-positive Breast Cancer
  • Cancer
  • Breast Cancer
  • Brain Metastasis
  • Leptomeningeal Metastases

Treatment Effectiveness

Study Objectives

2 Primary · 17 Secondary · Reporting Duration: Up to 15 years

Day 21
Incidence of dose limiting toxicities (DLTs)
Year 15
Cytokine levels in the tumor micro-environment
HER2 antigen expression levels
HER2-CAR T cells detected in the tumor micro-environment
Immune cell subsets in the tumor micro-environment
Median overall survival
Year 1
Circulating tumor cells in the CSF
Cytokine levels in CSF
Cytokine levels in peripheral blood
Endogenous B cells in CSF and peripheral blood
HER2-CAR T cells cerebrospinal fluid (CSF) and peripheral blood
Host immune subsets (e.g. T cell inhibitory/exhaustion markers, activation markers, and effector memory T cells) in CSF and peripheral blood
Myeloid cells in CSF and peripheral blood
Month 12
Biomathematical modeling of tumor growth: perfusion and growth parameters based on serial brain magnetic resonance imaging
Disease response in central nervous system (CNS)
Median CNS progression-free survival
Systemic disease response
T cells in CSF and peripheral blood
Up to 15 years
Number of participants with treatment related adverse events

Trial Safety

Trial Design

1 Treatment Group

Treatment (HER2-CAR T cells)
1 of 1

Experimental Treatment

39 Total Participants · 1 Treatment Group

Primary Treatment: Chimeric Antigen Receptor T-Cell Therapy · No Placebo Group · Phase 1

Treatment (HER2-CAR T cells)
Biological
Experimental Group · 1 Intervention: Chimeric Antigen Receptor T-Cell Therapy · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,070 Previous Clinical Trials
41,129,075 Total Patients Enrolled
27 Trials studying HER2-positive Breast Cancer
1,511 Patients Enrolled for HER2-positive Breast Cancer
California Institute for Regenerative Medicine (CIRM)OTHER
59 Previous Clinical Trials
3,221 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
515 Previous Clinical Trials
2,248,041 Total Patients Enrolled
2 Trials studying HER2-positive Breast Cancer
75 Patients Enrolled for HER2-positive Breast Cancer
Jana L PortnowPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
42 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Participants who have had brain and/or leptomeningeal metastases that have not recurred are eligible to enroll in the study, but they cannot start treatment with HER2-CAR T cells until there is evidence of tumor progression/recurrence.
for the diagnosis of leptomeningeal metastasis Individuals who have been diagnosed with leptomeningeal metastasis may also have brain metastases, but this is not always the case
A person is eligible to have leukapheresis if at least 2 weeks have passed since their last dose of targeted agents, chemotherapy, or radiation
The participant has a cancer that is classified as HER2+ based on the results of an IHC test or a FISH test.
Participants must be able to understand and sign a written informed consent.
You are eligible to proceed with leukapheresis if you do not require more than 6 mg/day of dexamethasone (or the equivalent dose of another corticosteroid) on the day of leukapheresis.
The subject has either recurrent leptomeningeal metastases after intrathecal chemotherapy or untreated brain or leptomeningeal metastases and refuses to undergo radiation and/or intrathecal chemotherapy.
Screening for this study will require a Karnofsky performance status of at least 70.
The participant must have a life expectancy of at least eight weeks in order to participate.