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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) of expanded CD4 T cells
Secondary outcome measures
Clinical Benefit Rate (CBR) of DC1 vaccines and pepinemab/trastuzumab
Clinical Benefit Rate (CBR) of expanded CD4 T Cells
Overall Response Rate (ORR)
+1 moreTrial 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
Trastuzumab
2014
Completed Phase 4
~5190
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,464 Total Patients Enrolled
41 Trials studying Breast Cancer
5,780 Patients Enrolled for Breast Cancer
Vaccinex Inc.Industry Sponsor
11 Previous Clinical Trials
725 Total Patients Enrolled
Heather Han, MDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
31 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using or willing to use effective birth control methods if of childbearing potential.I have undergone a type of cell therapy treatment before.I am not pregnant or nursing.I do not have any serious illnesses that could interfere with the study.I do not have an active autoimmune disease or a history that requires long-term steroids.My breast cancer is HER2 positive and I am eligible for trastuzumab treatment.My breast cancer's hormone receptor status doesn't affect my eligibility; I can continue hormone therapy if positive.I do not have uncontrolled brain tumors or cancer in the lining of my brain.My HER2+ breast cancer worsened on trastuzumab, and I've had ≤3 chemotherapy treatments for it.You have a positive test for Hepatitis B or Hepatitis C virus, showing that you have an ongoing infection.I have not received a live vaccine in the last 30 days.I have not had chemotherapy or radiotherapy in the last 14 days.I am currently being treated for another type of cancer.My organ and bone marrow functions are normal as per recent tests.Your heart's pumping ability is higher than the normal range at the hospital.I have a tumor that can be measured by scans like CT or MRI.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: T-Cell therapy dose level 1
- Group 2: T-Cell therapy dose level 2
- Group 3: T Cell therapy dose expansion
- Group 4: T-Cell therapy dose level 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation still open for enrollment?
"Affirmative, according to information hosted on clinicaltrials.gov this trial is presently recruiting participants and has been since May 31st 2022. Last updated November 1st 2022, the study requires 28 individuals at a single site."
Answered by AI
How many participants are taking part in this experiment?
"Indeed, clinicaltrials.gov proves that this medical study is actively recruiting participants. This research was initially posted on May 31st 2022 and its most recent update occurred in November 1st of the same year. At present, 28 individuals need to be recruited from a single facility."
Answered by AI
To what extent can T-Cell therapy be deleterious to individuals?
"As this is a Phase 1 trial, meaning there is minimal evidence of efficacy and safety profiles, the team at Power has assessed T-Cell therapy's security as a score of 1."
Answered by AI
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