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
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.
- 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:
- Screening to confirm acceptance to the study.
- Leukapheresis to isolate T-cells which are then modified in the lab.
- The HER2-modified T cells will be given into the vein through an IV line.
- Trastuzumab antibody therapy will be infused.
- 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.
Susan Griffin | 617-276-5843 | [email protected]
Jessica Sachs, MD | (617) 286-6640 | [email protected]
Unum Therapeutics Inc.
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