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New RNA drug ORN252 tested in humans for first time

NCT ID NCT07439796

Knowledge-focused Sponsor: Orna Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study is testing a new experimental drug called ORN252 in 20 healthy adults. ORN252 is a type of RNA therapy wrapped in a fat particle, designed to help the body make a protein that targets certain immune cells. The main goal is to check if it is safe and how the body handles it. This is a first step and does not aim to treat any disease yet.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ORN252 (a lipid nanoparticle containing circular RNA that encodes a CAR protein targeting CD19)
What this could lead to
If safe, this could pave the way for future studies of ORN252 as a potential cancer therapy.
What could go wrong
This is a very early, small phase 1 trial in healthy people, not patients. It only tests safety and how the drug moves through the body, not whether it works against any disease. Side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male and female participants who are healthy as determined by the Investigator based on review of medical history, physical examination, and laboratory tests * Participant is willing and able to comply with study visits and other protocol requirements * Other protocol specific inclusion criteria may apply Exclusion Criteria: * Clinically significant history or presence of organ dysfunction * Use of any investigational product within 3 months, or 5 half-lives, whichever longer * Other protocol specific exclusion criteria may apply

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers - male and female

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nucleus Network

    RECRUITING

    Herston, Queensland, 4006, Australia

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