CAR-T cell therapy for dogs with CD20 positive B cell lymphoma
Amber Winter, CVT
Research Professional 2
[email protected]
612-624-1352
Study title
Evaluation of xenogeneic CAR-T cell therapy for canine CD20+ B Cell lymphoma
Purpose of study
Canine B-cell lymphoma resembles human non-Hodgkin’s lymphoma, a cancer now successfully treated with Chimeric Antigen Receptor T cells (CAR-T cells). CAR-T cells are “T immune” cells that are genetically reprogrammed to seek out cancer, recognize it like a lock and key, and destroy it. This is an initial pilot trial to test the safety of a CAR-T cell therapy product in dogs with canine B-cell lymphoma towards the identification of more cost-effective and effective therapy for dogs with this disease. Prior to the CAR-T therapy, dogs will receive the immunosuppressive combination of two chemotherapy drugs with the dual goal of 1) killing at least a proportion of cancer cells, and 2) make room in the body for the CAR-T cells to expand.
Eligibility criteria
Eligible dogs will match these criteria:
- all breeds allowed, except boxers
- weigh 15-50 kg (33-110 lbs)
- naive or relapsed lymphoma
- Disease stages 1-4, substage A only
- Cytologically confirmed lymphoma based on fine needle aspirates (FNA)
- CD20+ determined from send-out FNA sample (collected at screening visit)
- not currently receiving immunomodulatory drugs (Apoquel, mycophenolate, cyclosporine, or azathioprine)
- prednisone use is ok if a 72 hour wash out period prior to CAR-T administration is safe
- liver and kidney values within normal ranges as determined by blood and urine tests
- normal neutrophil count, normal platelet count, normal hematocrit, no evidence of hypercalcemia, no evidence of lymphoblasts in circulation
- disease does not involve the gastrointestinal tract, heart or lungs; patchy spleen/liver with disease infiltration may be acceptable provided substage a disease
Procedures
- Screening visit with physical exam, blood and urine collection, chest X-rays, abdominal ultrasound (possible sedation), lymph node measurements, fine needle aspirates (FNA) of lymph nodes. Within 1-3 days, we will determine if your dog has CD20-positive Diffuse Large B-cell Lymphoma (DLBCL). Dogs with positive tests can enroll, dogs with negative tests will not be able to enroll.
- First week
- Day -3: immunosuppression treatment with chemotherapy drugs, blood sampling, lymph node measurements and FNA. Dogs will go home with supportive medications to prevent side-effects of chemotherapy drugs.
- Day -2: immunosuppression treatment with chemotherapy drugs
- Day 0: exam and blood sampling, then CAR-T cells by IV infusion. Dogs will be hospitalized in the VMC until Day 1 so we can monitor them closely and provide any care needed, including hospitalization in the ICU if indicated.
- Day 1: exam, blood sampling, lymph node measurements and FNA, dogs go home with supportive medications
- Recheck visits at Day 7, 14 for exams, blood sampling, lymph node measurements and FNA.
- Day 21: study exit after recheck and lymph node progression assessment, exam, blood sampling, chest X-rays and abdominal ultrasound
Costs
The study is fully funded and will cover the costs of the visits outlined above, including the screening visit. Additional credits of up to $2000 ($1000 following Day 7 and Day 14 visits) will be made to the owners' VMC accounts only.