T-Cell therapy for HER2-positive Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Moffitt Cancer Center, Tampa, FL
HER2-positive Breast Cancer+1 More
T-Cell therapy - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to test the safety of Adoptive T-Cell therapy following the Dendritic Cell (DC1) study vaccine given in combination with pepinemab added to standard of care therapy, trastuzumab to help people with HER2 positive breast cancer.

Eligible Conditions

  • HER2-positive Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 36 months

Up to 36 months
Progression Free Survival (PFS)
Up to 6 months
Maximum Tolerated Dose (MTD) of expanded CD4 T cells
Overall Response Rate (ORR)
at 6 months
Clinical Benefit Rate (CBR) of DC1 vaccines and pepinemab/trastuzumab
Clinical Benefit Rate (CBR) of expanded CD4 T Cells

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

T Cell therapy dose expansion
1 of 4
T-Cell therapy dose level 2
1 of 4
T-Cell therapy dose level 1
1 of 4
T-Cell therapy dose level 3
1 of 4
Experimental Treatment

28 Total Participants · 4 Treatment Groups

Primary Treatment: T-Cell therapy · No Placebo Group · Phase 1

T Cell therapy dose expansionExperimental Group · 4 Interventions: T-Cell therapy, Trastuzumab, Dendritic Cell (DC1) Vaccine, Pepinemab · Intervention Types: Biological, Drug, Biological, Drug
T-Cell therapy dose level 2Experimental Group · 4 Interventions: T-Cell therapy, Trastuzumab, Dendritic Cell (DC1) Vaccine, Pepinemab · Intervention Types: Biological, Drug, Biological, Drug
T-Cell therapy dose level 1Experimental Group · 4 Interventions: T-Cell therapy, Trastuzumab, Dendritic Cell (DC1) Vaccine, Pepinemab · Intervention Types: Biological, Drug, Biological, Drug
T-Cell therapy dose level 3Experimental Group · 4 Interventions: T-Cell therapy, Trastuzumab, Dendritic Cell (DC1) Vaccine, Pepinemab · Intervention Types: Biological, Drug, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~9050

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months
Closest Location: Moffitt Cancer Center · Tampa, FL
Photo of moffitt cancer center 1Photo of moffitt cancer center 2Photo of moffitt cancer center 3
2009First Recorded Clinical Trial
6 TrialsResearching HER2-positive Breast Cancer
220 CompletedClinical Trials

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
486 Previous Clinical Trials
123,374 Total Patients Enrolled
7 Trials studying HER2-positive Breast Cancer
382 Patients Enrolled for HER2-positive Breast Cancer
Vaccinex Inc.Industry Sponsor
11 Previous Clinical Trials
716 Total Patients Enrolled
Heather Han, MDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
31 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients will be eligible regardless of ER/PR status which will be determined per 2020 ASCO/CAP guideline.
You have HER2 positive breast cancer and are candidates for trastuzumab therapy as per current standard of care.
You have HER2+ metastatic breast cancer and have received no more than 3 lines of cytotoxic chemotherapy in the setting of metastatic disease.
You must be able to understand and sign a written informed consent prior to registration on study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.