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HER2-Positive Advanced Solid Tumor Cancers - Healing Genes
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HER2-Positive Advanced Solid Tumor Cancers

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Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers

A Phase 1 Study of an Autologous ACTR T Cell Product in Combination With Trastuzumab, a Monoclonal Antibody, in Subjects With HER2-Positive Advanced Malignancies


Phase 1

DESCRIPTION:

Researchers in CT, TN, and TX need experimental drug trial participants with HER2-positive advanced malignancies. The investigatory treatment gene-modifies their own immune T-cells to make an antibody (HER2) to recognize and kill tumor cells. This will require leukapheresis to collect the T-cells, which are gene-modified in the lab before being returned to the patient. Additional antibody treatments against HER2-producing tumors will also be given.

Follow up to assess the safety and effectiveness of the drug to reduce the tumor will be required for at least a year.


PATIENT MUST:

  • Be 18 to 75 years of age
  • Have histologically-confirmed Her2 positive advanced solid tumor malignancy with documented disease progression during or immediately following the immediate prior therapy, or within 6 months of completing adjuvant therapy for subjects with breast cancer
  • Have a life expectancy of 6 months or greater
  • Not be pregnant or breastfeeding

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. The HER2-modified T cells will be given into the vein through an IV line.
  4. Trastuzumab antibody therapy will be infused.
  5. Follow up to assess the safety and effectiveness of the drug to reduce the tumor will be required for at least a year.

LOCATIONS & CONTACTS:
The study sites are:
Baylor Scott & White Medical Center in Dallas, TX, Map.
Sarah Cannon Research Institute/Tennessee Oncology, PLLC in Nashville, TN, (Map).
Yale Smilow Cancer Hospital in New Haven, CT, Map.
 
Contacts:
Susan Griffin  |  617-276-5843  |  [email protected]
Jessica Sachs, MD  |  (617) 286-6640  |  [email protected]
 
SPONSORS
Unum Therapeutics Inc.
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT03680560

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