Can an mRNA injection rebuild lymphatic flow and ease arm swelling?

NCT ID NCT07793656

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests an mRNA therapy called APERNAVEC in women with arm lymphedema that developed after breast cancer surgery. The treatment is injected into the skin of the affected limb, aiming to restore lymphatic flow and reduce swelling. Researchers will check how safe the injection is over six months and whether the procedure is feasible. The study includes women with moderate stage 2 lymphedema who have had the condition for at least six months.

What this could mean

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

Active substance
APERNAVEC, an mRNA therapy injected into the skin of the affected limb
What this could lead to
If it works, this could offer a new way to treat lymphedema by restoring lymphatic flow, reducing swelling and improving arm function.
What could go wrong
This is an early, small trial with only 9 participants, so results may not apply broadly. The injection could cause side effects, and the therapy may not restore lymphatic function as hoped.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 9 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Women who developed upper limb lymphedema after surgery for breast cancer hormone receptor positive (HR+) more than 5 years, * Age\> 18 years, * Body mass Index (BMI)\<40, * Stage 2 Lymphedema, moderate (defined by an increase in volume between 20 and 40% compare to the healthy limb), * Lymphedema evolving during at least 6 months, * Patient who adhere to optimized decongestive therapy, including a compression sleeve worn daily, integrated into an educational care pathway for the management of their lymphedema, * Patients information and signed written consent form, * Patients affiliated to a social security system. Exclusion Criteria: * HER2+ breast cancer triple positive, * Other aggressive breast cancers (including triple negative and inflammatory breast cancer), * Active cancer needing chemo- or radio-therapy, * Metastatic breast cancer, * Bilateral breast cancer, * Upper limb peripheral arterial disease ipsilateral to the lymphedema, * History of recent (\< 3 months) upper limb deep venous thrombosis ipsilateral to the lymphedema, * Previous shoulder or orthopedic surgery on lymphedematous arm * Any abnormality of the opposite arm (arm without lymphedema), * Trophic disorders on the lymphedematous arm, * Last episode of cellulitis less than six months, * Recurrent cellulitis, * Patient participating in a clinical trial or having participated in a clinical trial within the previous 3 months or within 5 half-lives of any investigational product Immunosuppressive and anti-inflammatory treatments (topical and anti-inflammatory dermocorticoids and oral corticosteroids) in the 10 days before the injection or within 5 half-lives. * Patient under judicial protection or enable to express consent, * Females who are or plan to be pregnant or breastfeeding during the course of this study, * Women of childbearing potential (WOCBP) who are sexually active and unwilling to use an adequate birth control method (hormonal or physical barrier), * History of cancer other than breast cancer (excepted basalcell carcinoma), * Any acute, chronic, or severe psychiatric condition that may interfere with participation in the study * Unstable, clinically significant neurologic, psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results. * Known allergy to bovine proteins * Vulnerable patients (persons deprived of their liberty by judicial or administrative decision, persons undergoing psychiatric treatment, persons admitted to a health or social establishment for purposes other than research) according to article L1121-6 of the Public Health Code.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  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

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Contacts and locations

Locations

  • CHU de Toulouse

    Toulouse, 31059, France

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