A Phase I Trial of Autologous CLL B Cells Transduced to Express Chimeric CD154 (ISF35)
NCT00779883 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2008-10-24
Summary
The study is a Phase I, dose-escalating, non-randomized, single institution clinical trial assessing the safety and efficacy of autologous Ad-ISF35-transduced CLL B cells administered as a single intravenous infusion in patients with chronic lymphocytic leukemia (CLL).
Conditions
Interventions
- BIOLOGICAL
-
ISF35
Subjects participating in this study will receive a single dose of 1x10\^8, 3x10\^8, or 1x10\^9 autologous Ad-ISF35-transduced CLL B cells.
Sponsors & Collaborators
-
Memgen, LLC
lead INDUSTRY
Principal Investigators
-
William G. Wierda, M.D., Ph.D. · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-06-30
- Primary Completion
- 2008-03-31
- Completion
- 2008-03-31
Countries
- United States
Study Locations
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