A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3

Part of paid clinical trials in La Jolla, California.

Sponsor
Replimune, Inc.
Study ID
NCT06887348
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Observational study with no interventions — OTHER
    This is an observational study and there will be no clinical interventions.

Study Details

This is a noninterventional, observational, long-term follow-up (LTFU) study. Patients in this study will be followed for 5 years from enrollment on this study to assess potential delayed risks of RPx products. Eligible participants for this LTFU study include patients who received at least 1 dose of an RPx product under the interventional parent study. Patients will be rolled over into this LTFU study after completion of the Replimune-sponsored parent study (ie, either completion of the LTFU in the parent study or withdrawal from the parent study). All patients in ongoing RPx studies will be asked to participate in this LTFU study so that the Sponsor can evaluate potential delayed risks.

Key Dates

Start date
Dec 12, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2035

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Patients who received at least 1 dose of an RPx [RP1, RP2, RP3]
    This is an observational study and there will be no clinical interventions.

Primary Outcome Measure

Evaluate the long-term safety of patients treated with an RPx product [ Time Frame: Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-0698
Soo Park, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UC San Diego Moores Cancer Center· La Jolla, CA

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