Patient Disease:
Canine Soft Tissue Sarcoma
Study Name:
Clinical Testing of Canine T cells Engineered to Target Osteosarcoma and Soft Tissue Sarcoma in
Combination with Oral Immunotherapy
Purpose of the study:
- To evaluate the safety and anti-cancer activity of fibroblast activation protein (FAP) targeted chimeric antigen receptor (CAR) T cells, alone or in combination with orally administered immunotherapy drugs, in dogs with soft tissue sarcoma
Primary Eligibility Criteria:
- Weight at least 11 kg (24.2 lb)
- Confirmed diagnosis of soft tissue sarcoma that is able to be removed surgically
- Adequate blood work
- 2-week washout any anti-cancer therapy; no prior immunotherapy
- No uncontrolled or recently diagnosed immune-mediated disease (ie. Immune-mediated hemolytic
anemia/thrombocytopenia), or any condition or be taking any medication that might affect immune system function - Pets must come to CSU for all visits related to the clinical trial
Study Protocol:
- At the time of enrollment, dogs will have blood drawn for CAR T cell generation and a tumor biopsy
- Recheck 10 days later for oral chemotherapy to reduce the number of normal white blood cells to maximize effectiveness of CAR T cells
- CAR T infusion 14 days after blood draw with monitoring in-hospital all day
- Rechecks 3 & 7 days after infusion; surgery to remove tumor 14 days after
- Rechecks 2 & 6 weeks after surgery, then study is complete
Owner Responsibilities:
- You are responsible for the initial testing to determine study eligibility and any other tests recommended by your pet’s oncologist
- You are responsible for the costs related to the surgery to remove the tumor beyond what is
covered by the study - You are expected to make and keep all appointments associated with the study
Financial Incentives:
- All costs related to the study will be covered up to an amount of $3,200 as well as provide $1,000 towards the cost of surgical removal of the primary tumor
- Study will also cover the costs of the oral immune drugs (toceranib and losartan) other than the pharmacy dispensing fee and the tumor biopsy
- There are also funds available to cover the costs of treatment of any side effects related to the study procedures (up to $500)
If you have further questions about any of our clinical trials, please submit an online consult form. Your consult will then be directed to our trials team. Requests are typically returned within 5 business days.