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

Launched by BAYLOR COLLEGE OF MEDICINE · Feb 1, 2024

Keywords

ClinConnect Summary

This clinical trial, called TRAIL-R2, is exploring a new treatment for patients with metastatic breast cancer that has a specific protein called HER2. The researchers are testing a special type of immune cell known as CAR T cells, which are designed to recognize and attack cancer cells. The main goals of the study are to find the safest and most effective dose of these CAR T cells, understand how long they remain in the body, identify any side effects, and determine if they can effectively kill the HER2-positive breast cancer cells.

To be eligible for this study, patients must be between 18 and 80 years old, have metastatic or locally recurrent breast cancer that expresses HER2, and their cancer must have worsened after at least one standard treatment. Participants will receive the modified CAR T cells and will be closely monitored for their response to the treatment and any side effects. It's important to know that this is an experimental treatment and is not yet approved by the FDA. If you or a loved one is considering participation, it’s essential to discuss the potential risks and benefits with a healthcare provider.

Gender

ALL

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