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Breast Cancer - Healing Genes
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Breast Cancer

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TAA Specific Cytotoxic T Lymphocytes in Patients With Breast Cancer (TACTIC)

Tumor Associated Antigen (TAA) Specific Cytotoxic T Lymphocytes Administered in Patients With Breast Cancer


Phase 2

DESCRIPTION:

The Baylor College of Medicine is conducting a trial of an experimental treatment for recurrent breast cancer, which has already proven successful in other cancers. The researchers intend to use a method to genetically engineer immune T-cells to recognize cell proteins that are specific to the cancer cell. First blood is drawn and the T-cells isolated, modified, and multiplied in a lab. Then they are returned to the patient in 2 injections given 28 days apart. After a 6 week evaluation, if the patient’s disease hasn’t responded, they will be eligible for up to 6 further monthly doses. Follow up will last ~12 weeks post last dose..


PATIENT MUST:

  • Be 18 years to 80 years old
  • Have breast cancer with metastatic or locally recurrent unresectable disease
  • Have a life expectancy greater than or equal to 12 weeks
  • Use birth control methods for 6 months after the T cell infusion
  • Not be pregnant or lactating

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Recovery of the blood for T-cell separation and modification.
  3. 2 injections will be given 28 days apart.
  4. After a 6 week evaluation, if the patient’s disease hasn’t responded, they will be eligible for up to 6 further monthly doses.
  5. Follow up will last ~12 weeks post the last dose.

LOCATIONS AND CONTACTS:

The study sites are at the Houston Methodist Hospital, Map, and Smith Clinic of Harris Health System, Map.

Contacts:

Mothaffar F Rimawi, MD  |  713-798-1311  |  [email protected]

Catherine Robertson  |  832-824-4594  |  [email protected]

 

SPONSOR INFORMATION:

Baylor College of Medicine

The Methodist Hospital System

Center for Cell and Gene Therapy, Baylor College of Medicine

The National Cancer Institute (NCI)

Cancer Prevention Research Institute of Texas

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03093350

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