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RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients will only get one dose of HTR2 T cells during the infusion."
  • "If the patient has a good response and tolerance, we may be able to repeat infusion in the future."
  • "Investigators will obtain one tissue biopsy within 4 weeks after infusion and as clinically indicated thereafter."
  • "If additional clinically indicated tumor biopsies are obtained, investigators will ask for a portion of the sample for research."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests HTR2 T cells, immune cells changed with genes to help fight breast cancer with a protein called HER2. It is for adults whose cancer has spread or returned nearby, cannot be removed by surgery, and has worsened after treatment. Researchers want to find the highest safe dose, learn the side effects, and see how long the cells last and whether they fight cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 80 years old, of any sex.
  • You have breast cancer that has spread to other parts of the body or returned nearby and cannot be removed by surgery.
  • Your cancer tests show HER2 at a level of 1+, 2+, or 3+.
  • Your cancer has worsened after the first standard treatment. You may have had more than one treatment.
  • Your cancer can be measured or checked using the study’s rules.
  • Your liver, kidney, and blood tests meet the study’s limits. Your blood oxygen level is above 90% without extra oxygen.
  • You can care for yourself and are up and about at least half of your waking hours. You have been off standard or experimental cancer treatment for 3 weeks before joining.
  • You can understand the study and give written consent.

Who can't join

  • You are pregnant or breastfeeding.
  • You have an active bacterial, viral, or fungal infection that is not controlled.
  • You currently take steroid medicine that affects the whole body at a dose above the study’s limit: more than 0.5 mg/kg/day of prednisone or an equal dose of another steroid.
  • Your heart’s main pumping chamber pumps out less than 55% of its blood with each beat.
  • You have cancer that has spread to the brain and is getting worse.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Procurement Inclusion Criteria: 1. Any patient between 18-80 years of age regardless of sex, with a diagnosis of metastatic or locally recurrent unresectable HER2 positive breast cancer. 2. HER2 tumor expression1+, 2+ or 3+ by IHC 3. The disease must have progressed after standard first line therapy. Patients are still eligible if they have failed more than one line of therapy. 4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. Treatment Inclusion Criteria: 1. 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. 2. Measurable or evaluable disease per RECIST 1.1 criteria. 3. HER2 tumor expression 1+, 2+ or 3+ by IHC. 4. Bilirubin ≤ 3x upper limit of normal. 5. AST and ALT ≤ 3x upper limit of normal 6. Hemoglobin ≥ 7 g/dl (may be transfused values) 7. Serum creatinine \< 2 x the upper limit of normal. 8. Pulse oximetry of \> 90% on room air. 9. Off conventional or investigational therapy for 3 weeks prior to study entry. 10. ECOG Performance Status ≤ 2 11. The patient is able to understand and give informed consent to study related procedures and treatments. Procurement Exclusion Criteria: 1. Known pregnancy or actively breast feeding. 2. Active and uncontrolled bacterial, viral, or fungal infection. 3. Patients with current use of systemic corticosteroids (Prednisone equivalent \>0.5mg/kg/day). 4. Patients with abnormal left ventricular function (LVEF \<55%) 5. Patients with brain metastases that are progressing. Treatment Exclusion Criteria: 1. Pregnant or breast feeding 2. Active and uncontrolled bacterial, viral or fungal infection 3. Patient with current use of systemic corticosteroids (prednisone equivalent \>0.5 mg/kg/day. 4. Patients with abnormal left ventricular function (LVEF \<55%). 5. Patients with brain metastases that are progressing

Study sites (1)

TX