← Back to Search

Cancer Vaccine

T-Cell Therapy + Vaccine + Pepinemab/Trastuzumab for Breast Cancer

Phase 1

Recruiting

Led By Heather Han, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have a histologically confirmed HER2 positive breast cancer and must be candidates for trastuzumab therapy as per current standard of care. (HER2 positive breast cancer is defined by tumor tissue HER2 overexpression and or tumor HER2 amplification per ASCO/CAP criteria.)

Must have had disease progression while on trastuzumab for the treatment of HER2+ MBC and received no more than 3 lines of cytotoxic chemotherapy in the setting of metastatic disease.

Must not have

Patients previously treated with any form of adoptive cell transfer therapy.

Female patients who are pregnant or nursing are not eligible.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new cancer therapy that uses the patient's own immune cells to fight the cancer.

Who is the study for?

This trial is for adults with HER2 positive breast cancer who have seen their disease progress while on trastuzumab and have had no more than three lines of chemotherapy for metastatic cancer. They must be in good health otherwise, not pregnant or nursing, without a history of certain viruses (HIV, Hepatitis B/C), autoimmune diseases, or recent vaccines.

What is being tested?

The study tests Adoptive T-Cell therapy after a Dendritic Cell vaccine combined with pepinemab and standard trastuzumab treatment. It aims to improve outcomes for those with advanced HER2 positive breast cancer by enhancing the body's immune response.

What are the potential side effects?

Potential side effects may include typical reactions from immunotherapy such as flu-like symptoms, fatigue, risk of infection, possible organ inflammation due to an overactive immune system, and complications related to heart function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My breast cancer is HER2 positive and I am eligible for trastuzumab treatment.

Select...

My HER2+ breast cancer worsened on trastuzumab, and I've had ≤3 chemotherapy treatments for it.

Select...

My organ and bone marrow functions are normal as per recent tests.

Select...

I have a tumor that can be measured by scans like CT or MRI.

Select...

I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have undergone a type of cell therapy treatment before.

Select...

I am not pregnant or nursing.

Select...

I do not have any serious illnesses that could interfere with the study.

Select...

I do not have an active autoimmune disease or a history that requires long-term steroids.

Select...

I do not have uncontrolled brain tumors or cancer in the lining of my brain.

Select...

I have not received a live vaccine in the last 30 days.

Select...

I have not had chemotherapy or radiotherapy in the last 14 days.

Select...

I am currently being treated for another type of cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD) of expanded CD4 T cells

Secondary study objectives

Clinical Benefit Rate (CBR) of DC1 vaccines and pepinemab/trastuzumab

Clinical Benefit Rate (CBR) of expanded CD4 T Cells

Overall Response Rate (ORR)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: T-Cell therapy dose level 3Experimental Treatment4 Interventions

Participants will begin treatment with pepinemab and trastuzumab, and begin DC1 vaccines. After 6 weeks of DC1 vaccines, blood will be collected for t-cell therapy, and patients will then be treated with IL-15 Expanded HER2 specific CD4+ Th1 cell .5-2.5 x 10\^9, IL-7 and Expanded HER2 specific CD4+ Th1 cell .5-2.5 x 10\^9.

Group II: T-Cell therapy dose level 2Experimental Treatment4 Interventions

Participants will begin treatment with pepinemab and trastuzumab, and begin DC1 vaccines. After 6 weeks of DC1 vaccines, blood will be collected for t-cell therapy, and patients will then be treated with IL-15 Expanded HER2 specific CD4+ Th1 cell .25-1.2 x 10\^9, IL-7 and Expanded HER2 specific CD4+ Th1 cell .25-1.2 x 10\^9.

Group III: T-Cell therapy dose level 1Experimental Treatment4 Interventions

Participants will begin treatment with pepinemab and trastuzumab, and begin DC1 vaccines. After 6 weeks of DC1 vaccines, blood will be collected for t-cell therapy, and patients will then be treated with IL-15 Expanded HER2 specific CD4+ Th1 cell 0.5.0-2.5 x 10\^8, IL-7 and Expanded HER2 specific CD4+ Th1 cell 0.5.0-2.5 x 10\^8.

Group IV: T Cell therapy dose expansionExperimental Treatment4 Interventions

Participants will begin treatment with pepinemab and trastuzumab, and begin DC1 vaccines. After 6 weeks of DC1 vaccines, blood will be collected for t-cell therapy, and patients will then be treated with CD4 treated t-cells at the maximum tolerated dose determined.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pepinemab

2021

Completed Phase 2

~80

Trastuzumab

2014

Completed Phase 4

~5190