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MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients
NCT04651634 · View on ClinicalTrials.gov ↗
Study Summary
The proposed study in patients with previously untreated locally advanced head and neck squamous cell carcinoma (HNSCC) is designed to evaluate the efficacy and safety of three different doses of MIT-001 compared to the placebo in prevention of oral mucositis (OM) in patients with HNSCC who are undergoing concurrent chemoradiotherapy (CCRT).
Conditions Studied
Interventions
- DRUG MIT-001 plus CCRT
Study Locations (16)
Other
- Keimyung University Dongsan Hospital — Daegu
- Chungnam National University Hospital — Daejeon
- National Cancer Center — Goyang-si
- Seoul National University Bundang Hospital — Gyeonggi-do
- Inha University Hospital — Incheon
- Seoul National University Hospital — Seoul
- Korea University Guro Hospital — Seoul
- Hanyang University Seoul Hospital — Seoul
Arizona
- Banner MD Anderson Cancer Center — Gilbert
California
- Norris Comprehensive Cancer Center — Los Angeles
Kansas
- Cancer Center of Kansas — Wichita
New York
- James P. Wilmot Cancer Center — Rochester
North Carolina
- Wake Forest Baptist Health - Comprehensive Cancer Center — Winston-Salem
Ohio
- James Cancer Hospital Solove Research Institute — Columbus
Gyeonggi-do
- The Catholic University of Korea Saint Vincent's Hospital — Suwon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-06-21 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04651634
The ClinicalTrials.gov registry entry for NCT04651634 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MitoImmune Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention — of which MIT-001 plus CCRT is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04651634 reports 16 study locations spanning 9 distinct geographic areas — top geographies include Other, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04651634 about?
NCT04651634 is a clinical study titled "MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients". The proposed study in patients with previously untreated locally advanced head and neck squamous cell carcinoma (HNSCC) is designed to evaluate the efficacy and safety of three different doses of MIT-001 compared to the placebo in prevention of oral mucositis (OM) in patients with HNSCC who are unde...
What is the current status of trial NCT04651634?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2021-06-21. Estimated completion is 2025-12-31.
What conditions does trial NCT04651634 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Oral Mucositis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04651634?
The interventions under investigation include: MIT-001 plus CCRT (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04651634?
This trial is sponsored by MitoImmune Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04651634 being conducted?
This trial has 16 study locations across Arizona, California, Kansas, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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