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CAR T-cell Therapy

HER2 BATs for Breast Cancer

Phase 1
Waitlist Available
Led By Camilo Fadul, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through each participant's death or for 2 years following study treatment
Awards & highlights

Study Summary

This trial will test whether using HER2 BAT cells can help to shrink or slow the growth of breast cancer that has spread to the membranes around the brain and spinal cord (leptomeningeal metastases).

Eligible Conditions
  • Breast Cancer
  • Metastases

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through each participant's death or for 2 years following study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and through each participant's death or for 2 years following study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of adverse events
Frequency of adverse events (AEs)
Number of participants achieving at least 80% of the planned HER2 BATs dose.
+4 more
Secondary outcome measures
Correlation of clinical and immune response characteristics to overall survival
Correlation of clinical and immune response characteristics to progression-free survival
Immune shift: Determination of anti-Her2 antibodies
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Test dose then 8 doses HER2 Bi-armed activated T-cells (BATs)Experimental Treatment1 Intervention
Approximately 4 weeks following registration and blood collection, participants are given a test dose of HER2 BATs followed by 8 weekly infusions. Infusions are given intraventricularly.

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,245,028 Total Patients Enrolled
10 Trials studying Breast Cancer
2,042 Patients Enrolled for Breast Cancer
Camilo Fadul, MDPrincipal InvestigatorUniversity of Virginia
3 Previous Clinical Trials
22 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aims have been mapped out to be achieved with this experiment?

"The primary objective of this trial is to assess the number of participants that achieve 80% or more of their intended HER2 BATs dosage. Secondary objectives include evaluating immune shifts triggered by Her2 BATs, in vitro cytotoxicity assays and/or IFN-γ EliSpots against breast cancer cell lines, as well as exploring correlations between imaging results, pathology information, clinical data and immune responses with overall survival rates. Adverse events will be tracked from the first protocol related procedure through 30 days post last infusion of BATS; serious adverse effects associated with study treatment will also be collected after this period."

Answered by AI

How many individuals have committed to participating in this trial thus far?

"Affirmative. The clinical trial database on clinicialtrials.gov indicates that this study is currently recruiting participants, with 16 individuals needed from a single site. It was initially posted in February 2019 and the data was updated most recently in August 2021."

Answered by AI

Is HER2 BATs a secure method of treatment for individuals?

"Due to the preliminary nature of this Phase 1 trial, we have assigned a score of 1 on our safety scale for HER2 BATs. This is because there is still little data with regards to its efficacy and risk profile."

Answered by AI

Is this experiment currently seeking participants?

"Correct. Clinicaltrials.gov attests that this investigation, which was first advertised on February 26th 2019, is still searching for applicants. 16 participants are being accepted at a single medical site."

Answered by AI
Recent research and studies
Clinical Cancer ResearchJournal
Targeted T-cell Therapy in Stage IV Breast Cancer: A Phase I Clinical Trial
Lum, Lawrence G., Archana Thakur, Zaid Al-Kadhimi, Gerald A. Colvin, Francis J. Cummings, Robert D. Legare, Don S. Dizon, et al.. 2015. “Targeted T-cell Therapy in Stage IV Breast Cancer: A Phase I Clinical Trial”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-14-2280.
Prostate CancerJournal
Phase I Study of Anti-cd3 X Anti-her2 Bispecific Antibody in Metastatic Castrate Resistant Prostate Cancer Patients
Vaishampayan, Ulka, Archana Thakur, Ritesh Rathore, Nicola Kouttab, and Lawrence G. Lum. 2015. “Phase I Study of Anti-cd3 X Anti-her2 Bispecific Antibody in Metastatic Castrate Resistant Prostate Cancer Patients”. Prostate Cancer. Hindawi Limited. doi:10.1155/2015/285193.
Clinical Cancer ResearchJournal
Targeted T-cell Therapy in Stage IV Breast Cancer: A Phase I Clinical Trial
Lum, Lawrence G., Archana Thakur, Zaid Al-Kadhimi, Gerald A. Colvin, Francis J. Cummings, Robert D. Legare, Don S. Dizon, et al.. 2015. “Targeted T-cell Therapy in Stage IV Breast Cancer: A Phase I Clinical Trial”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-14-2280.
clinicaltrials.govStudy
BATs in Patients With Breast Cancer and Leptomeningeal Metastases
Camilo E. Fadul, MD 2019. "BATs in Patients With Breast Cancer and Leptomeningeal Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03661424.
~0 spots leftby Apr 2025
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