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Advanced Sarcoma - Healing Genes
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Advanced Sarcoma

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Her2 Chimeric Antigen Receptor Expressing T Cells in Advanced Sarcoma

Administration of Her2 Chimeric Antigen Receptor Expressing T Cells for Subjects With Advanced Sarcoma (HEROS)


Phase 1

DESCRIPTION:

Researchers at the Houston Methodist Hospital and Texas Children’s Hospital seek patients with advanced sarcoma to trial an investigatory treatment that gene-modifies their own immune T-cells to make an antibody against HER2 to recognize and kill sarcoma cells. After leukapheresis to collect the T-cells, they are gene-modified in the lab, then returned to the patient following chemotherapy.

Study participants will be hospitalized for chemotherapy for 7 days, then the investigatory drug  injection, then be followed for 6 weeks. If the patient has stable disease (the tumor did not grow) or there is a reduction in the size of the tumor on imaging studies after the T-cell infusion, they can receive additional doses of the T cells at 6 to 12 weeks intervals. For the first two subsequent HER2-specific T-cell infusions, patients will be able to receive additional chemotherapy.


PATIENT MUST:

  • Have a diagnosis of refractory HER2-positive sarcoma or metastatic HER2-positive osteosarcoma, not treatable by surgical resection
  • Have a life expectancy of 6 weeks or greater
  • Be willing to use contraception for 6 months after the treatment

THE STUDY INVOLVES:

  1. Screening to confirm acceptance to the study.
  2. Leukapheresis to isolate T-cells which are then modified in the lab.
  3. Chemotherapy for 7 days.
  4. The HER2-modified T cells will be given through an IV line into the vein. The injection will take between 1 and 10 minutes. The patient will be followed in the clinic after the injection for 1 to 4 hours.
  5. Follow up will be required for 6 weeks. If the patient has stable disease (the tumor did not grow) or there is a reduction in the size of the tumor on imaging studies after the T-cell infusion, they can receive additional doses of the T cells at 6 to 12 weeks intervals. For the first two subsequent HER2-specific T-cell infusions, patients will be able to receive additional chemotherapy.

LOCATIONS & CONTACTS:
The study sites are at Houston Methodist Hospital (Map) and at Texas Children’s Hospital in Houston, TX (Map).

Contacts:
MEENAKSHI G HEGDE, MD  |  832-824-4840  |  [email protected]
Catherine Robertson  |  832-824-4594  |  [email protected]
 
SPONSORS
Baylor College of Medicine
Texas Children’s Hospital
The Methodist Hospital System
Center for Cell and Gene Therapy, Baylor College of Medicine
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT00902044

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