NCT07302945

Brief Summary

Following oncolytic virus (OV) administration, the host immune response is initiated immediately and evolves dynamically. However, in clinical OV therapy, it is virtually impossible to capture these immune events in real time. To address this gap, the principal investigator conducted a high-resolution immune monitoring study in a healthy volunteer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jan 2022

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2022

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2022

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
Last Updated

December 26, 2025

Status Verified

October 1, 2025

Enrollment Period

10 days

First QC Date

November 16, 2025

Last Update Submit

December 23, 2025

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

  • Changes in ANC(absolute neutrophil count) over time

    4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16

  • Changes in lymphocytes count over time

    4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16

Secondary Outcomes (1)

  • FLow cytometry

    4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16

Other Outcomes (1)

  • Measurement of GFP expressing neutrophils following ex vivo infection with gfp report viral vector combined with CD surface phenotypes.

    4 hour, 48 hour, Day 8, Day 16

Study Arms (1)

OV Treated healthy arm

EXPERIMENTAL
Biological: OTS-412

Interventions

OTS-412BIOLOGICAL

After hospitalization, OTS-412 was infused for one hour.

OV Treated healthy arm

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A healthy adult

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Medical college

Busan, 50612, South Korea

Location

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2025

First Posted

December 24, 2025

Study Start

January 4, 2022

Primary Completion

January 14, 2022

Study Completion

May 2, 2022

Last Updated

December 26, 2025

Record last verified: 2025-10

Locations

KR(1)