NCT06251544 · Baylor College of Medicine
TRAIL-R2 and HER2 Bi-Specific Chimeric Antigen Receptor (CAR) T Cells for the Treatment of Metastatic Breast Cancer
What this study is about
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.
View original scientific description
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.
Interventions
GENETIC
HTR2 T Cells
Arm A -- Two dose levels will be evaluated: Dose level One: 1.00E+06 Dose level Two: 1.00E+07
GENETIC
HTR2 T Cells
Arm B -- Two dose levels will be evaluated: Dose level Two: 1.00E+07 Dose Level Three: 1.00E+08
Primary outcome measures
Dose-limiting toxicity (DLT) rate
Time frame: 4 weeks after first infusion
Rate of incidents of dose limiting toxicity by dose levels.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Houston, Texas
Collaborators
Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 24, 2026 · Source of record for eligibility and locations