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NCT07102394 · ClinicalTrials.gov registry record · Phase 1
Feasibility and Tolerability of IMLYGIC for the Treatment of Cutaneous Neurofibromas in Adults With NF1
A Phase 1 study of NF1 and Neurofibromatosis, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT07102394: Recruiting Phase 1 study of NF1 and Neurofibromatosis, sponsored by Johns Hopkins University.
NCT07102394 is a Phase 1 study of NF1 and Neurofibromatosis that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 10 participants, below the 79-participant average among 6 other NF1 trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07102394, a Phase 1 study of NF1 and Neurofibromatosis, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to establish the foundation for a new therapy for neurofibromatosis Type I (NF1)-related cutaneous neurofibromas (cNFs) by assessing the feasibility and efficacy of IMLYGIC in adults with NF1 and cNFs who desire local treatment of their cNF due to disfigurement, progression, pain, itching or other concerns. This is a single institutional Phase 1 study with a safety run-in to assess the feasibility and efficacy of IMLYGIC monotherapy in NF1 patients with cNFs. Each 28-day treatment cycle will be defined as intralesional administration of IMLYGIC administered on day 1 and 21 of Cycle 1 and days 7 and 21 for Cycles 2-4 for up to 4 cycles.
Primary Outcome
Feasibility is defined as ≥80% of participants receiving 4 treatments
Conditions Studied
Interventions
- DRUG Imlygic
Study Locations (1)
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-02 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT07102394 shows while recruiting
NCT07102394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 79-participant average among 6 other NF1 trials with a reported enrollment target (87% lower).
The record links to 6 conditions, with NF1 appearing as the primary indexed condition, and to 1 intervention - of which Imlygic is the first listed.
NCT07102394 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT07102394 about?
NCT07102394 is a clinical study titled "Feasibility and Tolerability of IMLYGIC for the Treatment of Cutaneous Neurofibromas in Adults With NF1". This study is designed to establish the foundation for a new therapy for neurofibromatosis Type I (NF1)-related cutaneous neurofibromas (cNFs) by assessing the feasibility and efficacy of IMLYGIC in adults with NF1 and cNFs who desire local treatment of their cNF due to disfigurement, progression, p...
What is the current status of trial NCT07102394?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2026-02. Estimated completion is 2027-12-31.
What conditions does trial NCT07102394 study?
This clinical trial studies the following conditions: NF1, Neurofibromatosis, Neurofibroma, Cutaneous Neurofibroma, Von Recklinghausen Disease.
What interventions are being tested in trial NCT07102394?
The interventions under investigation include: Imlygic (DRUG).
Who is sponsoring clinical trial NCT07102394?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07102394 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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