A Phase 1 interventional study of ISF35 in Chronic Lymphocytic Leukemia, sponsored by Memgen, LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-24.
Sponsored by Memgen, LLC · Phase 1, Interventional, and Treatment
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).
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 9 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Memgen, LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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.
Also known as: Ad-ISF35, AdISF35
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.
Time frame: Duration of the trial
Assess the anti-leukemia activity of a single intravenous dose by evaluating reduction in leukemia count, reduction in adenopathy and splenomegaly, and improvement in bone function.
Time frame: Duration of the trial
Assess the quality of life with ISF35 treatment.
Time frame: Two months
Assess pharmacodynamic endpoints including induction of T cell anti-leukemia immune responses, antibody production against autologous CLL B cells, and changes in bystander leukemia cell phenotype.
Time frame: Two months
This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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