CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 4 enrolled
Drug / intervention
ISF35biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00783588
NCT00783588Phase 1Completed
CompareCT.gov

A Phase 1B Extension Trial to Allow Repeat Dosing of Autologous CLL B Cells Transduced to Express Chimeric CD154 (ISF35) in Subjects Previously Treated in MDACC Protocol 2004-0914

Memgen, LLC·interventional·Posted Oct 31, 2008·Updated Oct 31, 2008

In Brief

A Phase 1 clinical trial evaluating ISF35 for Chronic Lymphocytic Leukemia. Completed, enrolled 4 participants across 1 site.

Detailed Summary

The study is a Phase Ib extension trial that will assess the toxicity, tolerability, and safety of up to two repeated administrations of 1x10\^8, 3x10\^8, or 1x10\^9 autologous Ad-ISF35-transduced CLL B cells given intravenously to patients with CLL who tolerated ISF35 in the prior Phase I infusion trial at M.D. Anderson.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 31, 2008
Enrollment StartMay 1, 2007
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.7 years ago

Interventions

ISF35biological

Subjects participating in this study will receive up to two doses of 1x10\^8, 3x10\^8, or 1x10\^9 autologous Ad-ISF35-transduced CLL B cells, depending on the dose they received in the previous Phase I trial.