NCT06251544RecruitingPhase 1

TRAIL-R2 and HER2 Bi-Specific Chimeric Antigen Receptor (CAR) T Cells for the Treatment of Metastatic Breast Cancer

(TRAILBLASER) TRAIL-R2 and HER2 Bi-Specific Chimeric Antigen Receptor T Cells for the Treatment of Metastatic Breast Cancer

Source: ClinicalTrials.gov · Last updated 24 Sept 2026

Brief summary (registry, in English)

The purpose of this study is to find the biggest dose of HTR2 T cells that is safe, to see how long these cells last in the body, to learn the side effects, and to see if these cells are able to fight and kill HER2 expressing breast cancer. Patients eligible for this study have metastatic breast cancer that has HER2 expression and has progressed on at least one line of therapy. This is a gene transfer research study using special immune cells called T cells. T cells are a type of white blood cell that helps the body recognize and fight cancer cells. The body has different ways of fighting diseases and no single way seems perfect for fighting cancer. This research combines two different ways of fighting cancer: antibodies and T cells. Antibodies are proteins that protect the body from infectious disease and possibly cancer. T cells, or T lymphocytes, are special blood cells that can kill other cells, including tumor cells. Both antibodies and T cells have shown promise treating cancer but have not been strong enough to cure most patients. Previous research has found that investigators can put genes into T cells that helps them recognize cancer cells and kill them. Investigators now want to see if by putting a new gene in those T cells to help recognize breast cancer cells expressing HER2 can kill the cancer cells. In clinical trials for various cancer types that express HER2, our center engineered a CAR that recognizes HER2 and put this CAR into patients own T cells and gave them back. Investigators saw that the cells did grow and patients did tolerate and respond to the treatment. Investigators will add a gene to the HER2 recognizing CAR T cells that will improve the T cells function. Investigators know that some immune cells in the body can lower T cells ability to kill cancer cells. Investigators have identified an antibody that will inactivate those immune suppressive cells thereby allowing T cells to survive better to recognize and kill cancer cells. This antibody targets the Trail-R2 receptor and is referred to as TR2. Also, investigators know that T cells need the support of cytokines to perform their immune functions. There is evidence showing that the addition of interleukin 15 (IL15) enhances CAR T cells ability to kill cancer cells. As a result, investigators also added IL15 to the HER2 and TR2 targeting CAR T cells (HTR2 T cells). The HTR2 T cells are an investigational product not approved by the Food and Drug Administration.

Status (registry): Recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 27 (estimated)
First submitted: 1 Feb 2024
Start date: 3 Aug 2026
Primary completion date: Jan 2029
Lead sponsor: Baylor College of Medicine
Diseases: Metastatic breast cancer
NCT number: NCT06251544

What you commit to

Study type: Interventional · Phase 1
Planned participants: 27
From 3 Aug 2026 to the primary completion date, Jan 2029
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

Procurement Inclusion Criteria:
Any patient between 18-80 years of age regardless of sex, with a diagnosis of metastatic or locally recurrent unresectable HER2 positive breast cancer.
HER2 tumor expression1+, 2+ or 3+ by IHC
The disease must have progressed after standard first line therapy. Patients are still eligible if they have failed more than one line of therapy.
Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
- Treatment Inclusion Criteria:
Patients between ages 18 and 80 years old with a diagnosis of either stage IV breast cancer or locally recurrent unresectable breast cancer. Disease must have progressed after standard first line therapy. Patients are still eligible if they have failed more than one line of therapy.
Measurable or evaluable disease per RECIST 1.1 criteria.
HER2 tumor expression 1+, 2+ or 3+ by IHC.
Bilirubin ≤ 3x upper limit of normal.
AST and ALT ≤ 3x upper limit of normal
Hemoglobin ≥ 7 g/dl (may be transfused values)
Serum creatinine \< 2 x the upper limit of normal.
Pulse oximetry of \> 90% on room air.
Off conventional or investigational therapy for 3 weeks prior to study entry.
ECOG Performance Status ≤ 2
The patient is able to understand and give informed consent to study related procedures and treatments.
- Procurement Exclusion Criteria:
Known pregnancy or actively breast feeding.
Active and uncontrolled bacterial, viral, or fungal infection.
Patients with current use of systemic corticosteroids (Prednisone equivalent \>0.5mg/kg/day).
Patients with abnormal left ventricular function (LVEF \<55%)
Patients with brain metastases that are progressing.
- Treatment Exclusion Criteria:
Pregnant or breast feeding
Active and uncontrolled bacterial, viral or fungal infection
Patient with current use of systemic corticosteroids (prednisone equivalent \>0.5 mg/kg/day.
Patients with abnormal left ventricular function (LVEF \<55%).
Patients with brain metastases that are progressing

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Houston Methodist Hospital Coordinator of this site? Confirm its status	Houston	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.