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NCT01579318 · ClinicalTrials.gov registry record · Phase 2
Phase II Intratumoral IL12 Plasmid Electroporation in Cutaneous Lymphoma
A Phase 2 study, sponsored by OncoSec Medical Incorporated.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01579318 is a Phase 2 study that was terminated before completion, run by OncoSec Medical Incorporated. The registered enrollment target is 2 participants.
The verdict
NCT01579318, a Phase 2 study, was terminated before completion, sponsored by OncoSec Medical Incorporated.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
A single arm, open label, multi-center, phase 2 study to assess the safety and anti-tumor activity of ImmunoPulse IL-12® in participants with stage IB to IIIB mycosis fungoides. ImmunPulseIL12® is the combination of intrtumoral interleukin-12 gene (also known as tavokinogene telseplasmid \[tavo\]) and in vivo electroporation-mediated plasmid deoxyribonucleic acid \[DNA\] vaccine therapy (tavo-EP) administered using the OncoSec Medical System (OMS). All participants may receive up to four cycles of treatment consisting of three treatment days, Days 1, 5 and 8, in a 12-week cycle as per Protocol version 6 (see Limitations and Caveats section of this record for protocol version information). Patients will receive intra-tumoral injection of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
Interventions
- BIOLOGICAL Tavokinogene Telseplasmid (tavo)
- DEVICE OncoSec Medical System (OMS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2012-06-08 |
| Est. Completion | 2014-06-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01579318
The ClinicalTrials.gov registry entry for NCT01579318 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OncoSec Medical Incorporated, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tavokinogene Telseplasmid (tavo) is the first listed.
NCT01579318 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01579318 about?
NCT01579318 is a clinical study titled "Phase II Intratumoral IL12 Plasmid Electroporation in Cutaneous Lymphoma". A single arm, open label, multi-center, phase 2 study to assess the safety and anti-tumor activity of ImmunoPulse IL-12® in participants with stage IB to IIIB mycosis fungoides. ImmunPulseIL12® is the combination of intrtumoral interleukin-12 gene (also known as tavokinogene telseplasmid \[tavo\]) a...
What is the current status of trial NCT01579318?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2012-06-08. Estimated completion is 2014-06-03.
What interventions are being tested in trial NCT01579318?
The interventions under investigation include: Tavokinogene Telseplasmid (tavo) (BIOLOGICAL), OncoSec Medical System (OMS) (DEVICE).
Who is sponsoring clinical trial NCT01579318?
This trial is sponsored by OncoSec Medical Incorporated, which has 5 total clinical trials registered on ClinicalTrials.gov.
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