Phase Ib Infusion + FCR Trial
Product: ISF35 (Active Immune Therapy) in combination with FCR
Location: Moores Cancer Center (UCSD)
Principal Investigator: Januario E. Castro, M.D.
Status: In Progress, Actively Recruiting
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Contacts / More Info
UCSD Moores Cancer Center
Vineeta Prasad
Phone: (858) 822-0337
Email: vprasad@ucsd.edu
ClinicalTrials.gov
Additional details for this trial including eligibility requirements and contact information can be found on ClinicalTrials.gov.
Web Site: ClinicalTrials.gov
Memgen is conducting a Phase Ib infusion plus FCR trial under the direction of Januario E. Castro, M.D., at the University of California, San Diego (UCSD).
Goals
The main goal of this trial is to determine the safety and efficacy of three repeat infusions of ISF35 in combination with chemotherapy (FCR) in subjects with relapsed, refractory, and/or 17p- chronic lymphocytic leukemia (CLL).
Previous Studies
Previous studies conducted using single and multiple doses of ISF35 showed remarkable results in subjects with high-risk and treatment-resistant CLL. Most importantly, ISF35 was well-tolerated with only minimal side effects, reduced CLL cells and lymph nodes in nearly every patient, and when combined with chemotherapy produced complete or partial remissions.
Study Design
This Phase 1b open label, non-randomized, single institution based clinical trial is designed to evaluate the safety and tolerability of a course of three infusions of 3x108 autologous Ad-ISF35-transduced CLL B cells followed by a standard regimen of three cycles of fludarabine, cyclophosphamide and rituximab (FCR). Subjects will receive ISF35 (Days 1, 15, and 29) in an outpatient infusion facility. Routine post-infusion evaluations following ISF35 administration will occur on one and seven days (Days 2, 8, 16, 22, 30 and 36) following ISF35 product administration. Beginning two weeks after the final infusion of ISF35, subjects will receive up to three courses of FCR at four-week intervals (Days 43, 71, and 99).
Following initiation of the chemotherapy regimen on day 43, subjects will be evaluated weekly following FCR administration. One month after the final chemotherapy cycle, subjects will be followed quarterly for a total of one year. In addition to obtaining information about the long-term safety of ISF35, subjects will be followed for any evidence of clinical response to repeat administrations of ISF35 and FCR treatment(s) or additional new treatments and duration of any clinical response. The subject’s participation in this study will be considered complete when he/she has completed the final scheduled follow-up on the 15th month following the first ISF35 infusion. For these follow-up time points, information regarding CLL status, treatment, and survival may be collected by phone. At completion of the 15-month study period, the subjects will be contacted by phone for survival and progression data on an annual basis.
Results
Results of this Phase I clinical trial will be published on this site as soon as they are available.
Contacts
UCSD Moores Cancer Center
Vineeta Prasad
Phone: (858) 822-0337
Email: vprasad@ucsd.edu
For More Information
Additional details for this trial including eligibility requirements and contact information can be found on ClinicalTrials.gov.
Web Site: ClinicalTrials.gov
Interested in staying up-to-date on this trial?
Get the latest news and announcements about this clinical trial by email.
Sign up for updates by email