Treatment of canine soft tissue sarcoma with FAP CAR-T cells

Soft tissue sarcoma (STS) represents a type of cancer that has been difficult to treat with immune-based therapies across multiple species, including pet dogs. The objective of this study, being led by investigators at Colorado State University (CSU) is to test a new type of immune therapy, called chimeric antigen receptor T (CAR-T) cells in pet dogs with naturally occurring STS. CAR-T cells are a type of immune cell, called T lymphocytes, that are engineered to express a specific receptor that binds to a protein expressed at high levels on tumor cells. In the case of STS, the protein of interest is FAP, which is expressed at high levels in many STS. Therefore, the CAR-T to be used in this study is engineered to express a receptor against FAP, which will help them bind to the STS tumor cells and initiate killing of the tumor. Therefore, the purpose of this study is to determine both the potential activity of the FAP CAR-T as well as any side effects that may be associated with its use in pet dogs with STS.

Inclusion Criteria

• Have a soft tissue sarcoma at least 2 cm in size and less than 8 cm in size. The sarcoma may be amenable to surgical resection or may be deemed non-resectable
• Weigh at least 11 kg (22 pounds)
• Have received no prior therapy or received chemotherapy and/or radiation therapy with recurrence of disease.
• Have no significant abnormalities on baseline bloodwork (CBC, chemistry, urinalysis) determined by the PIs (London, Regan)
• Have no significant comorbidities (heart, liver, kidney disease) that the PI deems incompatible with the study.
• Have completed any chemotherapy at least 14 days prior to enrollment.

Exclusion Criteria

• The presence of metastases that would result in an anticipated survival time of less than 3 months
• The dog is already receiving an experimental cancer therapeutic
• The dog is pregnant, lactating, or likely to become pregnant
• Presence of an autoimmune disease diagnosis other than atopic dermatitis
• Any of the following drugs before enrollment: a monoclonal antibody checkpoint inhibitor (e.g., Gilvetmab) and/or personalized T-cell based vaccine and immunotherapy

Client Benefits

For participation in this clinical study, all costs associated with treatment of your dog’s cancer with the FAP CAR-T cells through Day 56. Additionally, the study will provide $2,000 toward removal of your dog’s tumor. The study will cover treatment for side effects related to the tumor biopsy, cyclophosphamide administration and FAP CAR-T cell administration. It will not cover treatment for conditions unrelated to the study, such as bladder or ear infections, etc.

Contact

For questions regarding the clinical trial, please email clinicaltrials@tufts.edu.