Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Memgen, LLC |
---|---|
Information provided by: | Memgen, LLC |
ClinicalTrials.gov Identifier: | NCT00779883 |
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).
Condition | Intervention | Phase |
---|---|---|
Chronic Lymphocytic Leukemia |
Biological: ISF35 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Trial of Autologous CLL B Cells Transduced to Express Chimeric CD154 (ISF35) |
Enrollment: | 9 |
Study Start Date: | June 2006 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
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 another treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must have a diagnosis of B cell CLL, measurable disease, and an
NCI-WG indication for treatment with one of the following:
Subjects must have adequate hematologic, renal, hepatic, and coagulation function:
Adequate hematologic function:
Adequate renal function:
Adequate hepatic function:
Adequate coagulation tests:
Exclusion Criteria:
United States, Texas | |
University of Texas M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | William G. Wierda, M.D., Ph.D. | M.D. Anderson Cancer Center |
Responsible Party: | M.D. Anderson Cancer Center ( William G. Wierda, M.D., Ph.D. ) |
Study ID Numbers: | CLL-35-101 |
Study First Received: | October 23, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00779883 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Chronic lymphocytic leukemia CLL Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-Cell Immune System Diseases |
ISF35 Ad-ISF35 Immunotherapy Immune therapy Active immune therapy |
Lymphatic Diseases Leukemia Chronic Lymphocytic Leukemia Leukemia, Lymphoid Immunoproliferative Disorders |
Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Lymphoproliferative Disorders Leukemia, B-Cell |
Lymphatic Diseases Leukemia Neoplasms Leukemia, Lymphoid Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Leukemia, Lymphocytic, Chronic, B-Cell Lymphoproliferative Disorders Leukemia, B-Cell |