drugset / Trial / NCT00849524
Study of Repeat Intranodal Injection of Memgen's Cancer Vaccine, Ad-ISF35, in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Phase 2
Terminated
6 enrolled
Januario Castro, M.D.
FDA Office of Orphan Products Development · collabMemgen, LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase II, open label, fixed dose, repeat injection, single institution study. Eligible subjects will receive up to six doses of Ad-ISF35 injected directly into a selected lymph node under ultrasound guidance. The primary goal is to determine and monitor clinical and biological responses in patients treated with repeat intranodal injections of Ad-ISF35.
Timeline
- Start
- 2009-01
- Primary completion
- 2009-07
- Completion
- 2014-07
Outcome
Outcome not reported
Stopped: “drug supply became unavailable”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ISF35 | Cell therapy | 3.3e+10 vg | Other |