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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: Clinical Trial Phase 2 study, sponsored by OncoSec Medical Incorporated.
NCT01579318 is a Phase 2 study that was terminated before completion, run by OncoSec Medical Incorporated. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ORR is defined as the percentage of participants that achieved a complete response (CR) or partial response (PR) as assessed by mSWAT score. The mSWAT defines 3 lesion types and assigns each a weighing factor: patch (no induration or significant elevation)=1; plaque (induration, crusting, ulceration or poikiloderma)=2; tumor (solid or nodular ≥ 1 cm in diameter with evidence of deep infiltration and/or vertical growth)=4. Lesions are assessed by body surface area (BSA) where palm + fingers = app
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 |
Why NCT01579318 stopped before completion
NCT01579318 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Tavokinogene Telseplasmid (tavo) is the first listed.
NCT01579318 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01579318's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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