William G. Wierda, M.D., Ph.D. University of Texas MD Anderson Cancer Center

Gene and Vaccine Therapy

Gene Therapy with ISF-35 Transduced Autologous CLL Cell Vaccine

Update:

We originally proposed to conduct the phase II clinical trial of repeated doses of the ISF35 CLL vaccine for the Alliance project. Unfortunately, the pharmaceutical company that was sponsoring the clinical trial, Memgen, terminated the study before we were able to open it, even though we have been through all the regulatory steps for approval. Memgen reportedly had no financial resources for further ISF35 development at this time and therefore is not able to release ISF35, even for investigator-initiated studies.

Therefore, we focused our efforts on studying T cells from patients with CLL in order to understand the abnormalities in these cells that prevent effective immunization in these patients and prevent or dampen immune responses that are induced by vaccines, such as ISF35. By understanding these defects we may be able to develop strategies to bypass the defects or augment T cells responses in order to have a more productive T cell immune response. We have also been evaluating the T cell responses against leukemia cells in patients treated on the phase I ISF35 clinical trial.