Study Start Date: 12/01/2015
Study End Date: 11/30/2016

Pilot study of re-directed autologous T cell therapy for drug resistant or refractory CD20+ B cell lymphoma

This trial aims to determine the safety and efficacy of genetically re-directed T cells in dogs with B cell lymphoma. Despite successful induction chemotherapy, most dogs with B cell lymphoma relapse and eventually die of chemo-resistant disease. This on-going trial is testing whether T lymphocytes, genetically modified to express a chimeric antigen receptor against CD20, can be administered safely to dogs with relapsed B cell lymphoma and whether they can eliminate B cells and prolong overall survival. Eligible dogs have newly relapsed B cell lymphoma, have mild lymphadenopathy and have not received chemotherapy for at least 6 weeks. Chemotherapy adversely affects our ability to produce an autologous T cell product. 

Clinicians have observed improvement of LP after administering a drug called doxepin. However, no controlled studies have examined whether this effect is real, how frequently patients improve, how much they improve, and for how long the improvement is sustained.

Study Design:
Case series(prospective)

Sample Size:
10 dogs

Inclusion Criteria:

• Dogs with relapsed B-cell lymphoma (must be immunophenotyped)
• Ability to visit the University of Pennsylvania veterinary hospital to undergo screening and subsequent treatment and re-evaluation.

Exclusion Criteria:

• Dogs with naïve B-cell lymphoma (not yet relapsed)
• Dogs with T-cell lymphoma
• Dogs with relapsed B-cell lymphoma that have received anti-neoplastic chemotherapy within 6 weeks

Study Controls:
None

Study Endpoints:
Primary endpoints are safety and feasibility, and secondary endpoints are time to progression, overall survival, and persistence of CAR-T cells.

Costs/Reimbursements

If eligible and enrolled, the trial covers the costs of all staging tests, the costs to prepare and administer the autologous CAR-T cell product, the costs of all recheck visits, and up to $1500 towards care required for any adverse events resulting from product administration. Costs of adverse event care in excess of $1500, costs of rescue chemotherapy, and costs associated with care of unrelated health concerns are not covered by the trial.

Study Website

Further details of this study can be found here.

Full Disclosure information:
The study is funded by a grant from The Richard Lichter Charity for Dogs.
The investigator does not have a conflict of interest.
The study will be published if results are negative.
The study will be reported on VIN.
The authors will acknowledge VIN if the study is published.