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Gene therapy injection aims to cure radiation dry mouth

NCT ID NCT06714253

Disease control Sponsor: RiboX Therapeutics Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times

Summary

This early-stage trial tests a new treatment called RXRG001 for people with long-term dry mouth and low saliva after radiation therapy for cancer. The treatment is a genetic material delivered directly into the saliva glands to help them produce more fluid. The study involves 42 adults and will first check safety, then see if it improves saliva production.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RXRG001 (a genetic material that instructs cells to produce a protein to help saliva flow)
What this could lead to
If it works, this could lead to a treatment that restores saliva production and relieves chronic dry mouth in people who have had radiation for head and neck cancer.
What could go wrong
This is a very early, first-in-human trial with only 42 participants. The treatment is injected directly into the saliva gland, which carries risks like infection or swelling. It may not work or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria\* 1. At least 18 years of age 2. Free from recurrence of your cancer and never have had another form of cancer for at least 2 years 3. Suffering from xerostomia and/or hyposalivation and have xerostomia symptoms which were not resolved after treatment for at least 3 months 4. Both parotid glands on imaging examination Exclusion Criteria\* 1. Any active infection 2. Heart failure, reduced kidney function or uncontrolled diabetes (Hemoglobin A1c \>=8%) 3. History of autoimmune diseases known to potentially affect the salivary glands 4. Any malignancy, other than head and neck cancer within the past 3 years except for certain skin and cervical cancers 5. Active smoker or use tobacco products or have a history of substance or alcohol abuse * Other criteria apply

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Conditions

The condition(s) this trial relates to.

Xerostomia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Radiation-induced xerostomia and hyposalivation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • John Hopkins University, Sidney Kimmel Comprehensive Cancer Center

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • NYU Langone Medical Center

    RECRUITING

    New York, New York, 10016-6402, United States

  • Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Iowa Hospitals and Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States