Clinical-stage cell therapy company, Tessa Therapeutics announced the results of two independent Phase 1/2 trials of autologous CD30 CAR-T cell therapy in patients with relapsed or refractory Hodgkin Lymphoma.
Hodgkin Lymphoma is a type of cancer which stems from white blood cells known as lymphocytes. It is one of two types of cancers originating from the lymphatic system. In a recent publication released in the Journal of Clinical Oncology two investigator-sponsored Phase 1/2 trials evaluating the safety and efficacy of CD30 CAR-T cell therapy on patients with relapsed or refractory Hodgkin Lymphoma were released.
The trials were led by Baylor College of Medicine and the University of North Carolina Lineberger Comprehensive Cancer Centre. In the trial, autologous CD30 CAR-T cell therapy was tested which meant the use of the patient’s own cells for the therapy. Results of the trials demonstrated a positive responses and very favourable safety profile.
41 adult patients were enrolled for the trials with relapsed or refractory Hodgkin Lymphoma to receive the autologous CD30 CAR-T cell therapy after lymphodepletion with chemotherapy. Out of all the treated patients, 94 percent survival a year after treatment. 61 percent of the patients who showed complete responses had no evidence of recurrence one year later.
No serious or life-threatening complications were observed among the patients as compared to those seen in several CD19 CAR-T cell trials. Overall, the response rate in the 32 patients with active disease who received fludarabine-based lymphodepletion was 72 percent, including 19 patients (59%) with complete response.
“These data are significant, as they demonstrate that CAR-T cell therapy may be a safe and
effective treatment option for patients with Hodgkin lymphoma and potentially other lymphomas expressing the CD30 antigen,” said Dr. Natalie Grover, study co-first author, assistant professor in the UNC Department of Medicine and a UNC Lineberger member.
The university of North Carolina and Baylor College of Medicine have both granted Tessa an exclusive license to its patents, data and knowhow, for the further development and commercialization of this therapy.
“We have been working with Baylor and the University of North Carolina to confirm these
impressive results further in a Tessa-sponsored regulatory Phase 2 trial, which we aim to initiate this year,” said Ivan D. Horak, M.D., President of Research and Development at Tessa Therapeutics.
“Longer term, we seek to explore the potential of this therapy beyond Hodgkin’s lymphoma to CD30+ expressing Non-Hodgkin lymphomas, where there is a demonstrated unmet need.”
“We are excited to collaborate with Tessa. Their ability to run multi-center cell therapy clinical trials will be invaluable for the further development of this therapy,” said Helen Heslop, director of the Center for Cell and Gene Therapy and Dan L Duncan Chair at Baylor.