HTR2 CAR T Cells Targeting HER2 in Metastatic Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study tests a patient-derived CAR T cell therapy that combines HER2 targeting with TR2 and IL-15 genes to treat metastatic or unresectable HER2-positive breast cancer. The study aims to find the highest safe cell dose, understand how long the cells persist in the body, and document side effects while monitoring for anti-t cancer activity. T cells are collected from the patient, engineered in the lab, and then infused back over 5 to 10 minutes after thawing from storage. A safety switch (iCasp9) can be activated by Rimiducid if dangerous reactions occur. Dose may be increased up to two times based on tolerability and response.

Why it matters

Who can join: the full rules

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

Where it's running

• Houston Methodist Hospital
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Natalie Chen, MD — Baylor College of Medicine
• Study coordinator: Natalie Chen, MD
• Email: natalie.chen@bcm.edu
• Phone: 215-534-7895

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.