A Phase I Trial of Autologous CLL B Cells Transduced to Express Chimeric CD154 (ISF35)
Memgen's first TNF family derived product, ISF35, is a gene that encodes a recombinant
protein molecule that binds and activates human CD40+ B lymphocytes that are found on a vast
majority of malignant leukemias and lymphomas.
In this clinical trial, ISF35 will be introduced into the patients' CLL cells ex vivo using
a replication-defective adenovirus Ad5 encoding the ISF35 cDNA transgene. After this ex vivo
manipulation, the modified leukemia cells will be extensively washed and the amount of
remaining free virus is measured before the cells are reinfused into the patient. Following
ex vivo transduction, the CLL cells expressing ISF35 activate a therapeutic immune response
directed against the target leukemia cells.
This ascending-dose trial will be divided into three dosing cohorts to determine the
existence of a maximum tolerated dose.
Patients will be followed for 12 months after ISF35 administration or until initiation of
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess the toxicity, tolerability, and safety of 1x10^8, 3x10^8, and 1x10^9 autologous Ad-ISF35-transduced CLL B cells given as a single intravenous infusion in patients with CLL.
Duration of the trial
William G. Wierda, M.D., Ph.D.
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|University of Texas M.D. Anderson Cancer Center||Houston, Texas 77030|