Actively Recruiting
Phase II Study of RP2 as Immunoprevention in High-Risk Oral Precancerous Disease
Led by Glenn J. Hanna · Updated on 2026-04-23
25
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
Sponsors
G
Glenn J. Hanna
Lead Sponsor
R
Replimune, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this study is to understand the safety, tolerability, and potential efficacy of an injected immune therapy called RP2 to treat oral precancer conditions and prevent progression to an oral cancer. The name of the study drug involved in this study is: -RP2 (a genetically modified live Herpes Simplex V-1 strain)
CONDITIONS
Official Title
Phase II Study of RP2 as Immunoprevention in High-Risk Oral Precancerous Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of high-risk oral precancerous disease including proliferative leukoplakia, localized leukoplakia with moderate dysplasia not treated with surgery, erythroplakia, or lesions with specific genetic markers like 9p21 or TP53 mutations
- No head and neck cancer recurrence within the last 3 months if applicable
- Willingness to provide blood and tissue samples for biopsies
- At least one injectable measurable lesion 1 cm or larger
- Any smoking history allowed; tobacco use permitted during study
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Normal marrow function and coagulation profile within 21 days prior to registration
- Women of childbearing potential and men must agree to use effective contraception during and for 90 days after treatment, with pregnancy testing before starting RP2
You will not qualify if you...
- Prior treatment with oncolytic virus therapy
- Systemic infection requiring intravenous antibiotics
- Chronic use of systemic antivirals with antiherpetic activity
- Active significant herpetic infections or prior HSV-1 complications like keratitis or encephalitis
- Known acute or chronic hepatitis B or C infection unless effectively treated
- Known HIV infection unless required by local regulations
- History of prior stage III or IV invasive head and neck squamous cell carcinoma treated with surgery, radiation, or chemotherapy
- Long-term corticosteroid use exceeding prednisone 20 mg daily
- History of bone marrow or solid organ transplant
- Active malignancies except certain low-risk or treated cancers in remission for at least 2 years
- Significant bleeding events within the last 6 months posing risk for injection procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
G
Glenn Hanna, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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