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Phase II Study of RP2 as Immunoprevention in High-Risk Oral Precancerous Disease

NCT06623110 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-04-23

No results posted yet for this study

Summary

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

  • High-Risk Oral Precancerous Disease

Interventions

BIOLOGICAL

RP2 Injection

Genetically modified live HSV-1 virus, 3.0 mL single-use glass vials, via intralesional (into a lesion) injection per protocol.

Sponsors & Collaborators

  • Replimune, Inc.

    collaborator INDUSTRY

  • Glenn J. Hanna

    lead OTHER

Principal Investigators

  • Glenn Hanna, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2027-01-01
Completion
2029-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06623110 on ClinicalTrials.gov