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Virus Therapy
Gene Therapy for Radiation-Induced Dry Mouth
Phase 1
Waitlist Available
Led By John A Chiorini, Ph.D.
Research Sponsored by MeiraGTx, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No evidence of recurrence of primary malignancy by otolaryngology (ENT) assessment
All patients must have been disease-free of head and neck cancer for at least 5 years, a status to be determined at pre-dose screening using negative clinical exams and PET and or CT imaging of the neck and chest
Must not have
Any active respiratory tract infection in the 3 weeks prior to day 1 of the protocol
Uncontrolled ischemic heart disease: unstable angina, evidence of active ischemic heart disease on ECG, congestive heart failure (left ventricular ejection fraction < 45% on MUGA or echo) or cardiomyopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a gene therapy for dry mouth caused by radiation. The therapy involves infusing the gene AAV2hAQP1 into the parotid gland. The trial will test the safety of the therapy and whether it increases saliva production.
Who is the study for?
Adults who've had radiation therapy for head and neck cancer, resulting in dry mouth due to low saliva production from the parotid gland. They must be disease-free for at least 5 years (or 2 years if they had HPV positive oropharyngeal cancer), able to use barrier contraception, have no severe dental issues or allergies related to the trial, not smoke, and can stay in the hospital for 3-5 days.
What is being tested?
The safety of AAV2hAQP1 gene therapy is being tested. This involves a one-time infusion into one parotid salivary gland through the mouth. The goal is to see if this treatment can increase saliva production in those affected by dry mouth after radiation therapy.
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions at the injection site, general discomfort, changes in taste sensation due to salivary flow alteration, and possible immune responses against the viral vector used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ENT doctor found no signs of my cancer coming back.
Select...
I have been free from head and neck cancer for at least 5 years, confirmed by exams and imaging.
Select...
I am 18 years old or older.
Select...
I've had radiation therapy for head/neck cancer with a high dose to my salivary gland.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a lung infection in the last 3 weeks.
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I do not have uncontrolled heart problems like unstable angina or heart failure.
Select...
My parotid ducts cannot be seen on a special imaging test.
Select...
My salivary gland imaging shows a blockage that could affect treatment delivery, and my parotid gland is larger than 2.5 mL.
Select...
My diabetes is not under control (HbA1c > 10%).
Select...
I do not have untreated severe dental issues or pre-cancerous mouth conditions.
Select...
I use regular medication for asthma or COPD.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: single arm dose escalationExperimental Treatment1 Intervention
single arm dose escalation
Find a Location
Who is running the clinical trial?
MeiraGTx, LLCLead Sponsor
5 Previous Clinical Trials
290 Total Patients Enrolled
MeiraGTx UK II LtdLead Sponsor
14 Previous Clinical Trials
691 Total Patients Enrolled
National Institute of Dental and Craniofacial Research (NIDCR)NIH
306 Previous Clinical Trials
850,053 Total Patients Enrolled
1 Trials studying Dry Mouth
929 Patients Enrolled for Dry Mouth
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease like Sjogren's, lupus, or type I diabetes that is stable.I do not have an active infection requiring IV antibiotics 1 week before starting.I have not had a lung infection in the last 3 weeks.I do not have uncontrolled heart problems like unstable angina or heart failure.My parotid ducts cannot be seen on a special imaging test.My diabetes is not under control (HbA1c > 10%).My ENT doctor found no signs of my cancer coming back.I had HPV positive throat cancer and finished my treatment over 2 years ago.My medications for other health issues have been stable for at least 2 months.My salivary gland imaging shows a blockage that could affect treatment delivery, and my parotid gland is larger than 2.5 mL.I don't have any new major health issues that could stop me from completing the study.I have not received any live vaccines in the last 4 weeks.I agree to use barrier methods of contraception until AAV2hAQP1 is not found in my tests.I am a woman who cannot have children and will use barrier methods of birth control during the trial.I do not have untreated severe dental issues or pre-cancerous mouth conditions.I use regular medication for asthma or COPD.I have been free from head and neck cancer for at least 5 years, confirmed by exams and imaging.I am 18 years old or older.I can stay in the hospital for 3-5 days for each treatment phase.I haven't had cancer (other than skin or early cervical cancer) in the last 3 years.I am not on any immune-suppressing drugs, except for creams.I've had radiation therapy for head/neck cancer with a high dose to my salivary gland.
Research Study Groups:
This trial has the following groups:- Group 1: single arm dose escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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