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Secondary LymphedemaPhase 1/2LymphARNNCT07793656

mRNA Therapy to Restore Lymphatic Flow in Secondary Lymphedema

A Phase 1/2 study testing APERNAVEC in people with Secondary Lymphedema, run by University Hospital, Toulouse at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Lymphedema is a common complication of breast cancer treatment, affecting approximately a quarter of patients. Those affected can have an uncomfortable, unsightly and sometimes functionally impaired limb prone to episodes of superficial infection. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Secondary Lymphedema
What is being tested?
APERNAVEC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteFrance
Study dates
Oct 2026to Apr 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 21Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Charline DAGUZAN contact

05 61 77 84 90 ext. +33

daguzan.c@chu-toulouse.fr

France1 site

  • CHU de Toulouse

    Toulouse, 31059

    Julie MALLOIZEL DELAUNAY, Dr, 5 61 32 30 33 ext. +33, malloizel-delaunay.j@chu-toulouse.fr

Other trials in France

About this study

Lymphedema is a common complication of breast cancer treatment, affecting approximately a quarter of patients. Those affected can have an uncomfortable, unsightly and sometimes functionally impaired limb prone to episodes of superficial infection. The aetiology and pathophysiology of lymphedema in patients with breast cancer appear to be multifactorial and are still not fully understood.Although conservative treatment techniques can be very successful in controlling symptoms, they do not afford a cure. In this situation of unmet medical need, it is essential to find a new therapeutic solution to treat lymphedema. The approach of the LYMPHARN project is based on dual mRNA strategy delivered by FlashRNA® vector targeting both lymphatic endothelium and surrounding adipose tissue function.

Being tested
APERNAVEC
Keywords
secondary lymphedema, breast cancer, dual mRNA therapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APERNAVECDrug

    At day 0, the injection of APERNAVEC vector will be performed in intradermic tissue of the limb affected by lymphedema. Patient will be follow-up for 6 months

Study groups in NCT07793656
Study groupRoleWhat they receive
Experimental groupExperimentalPatients with secondary lymphedema will be included to receive eight injections of the APERNAVEC (APELIN-VEGF-C FlashRNA® vector) at D0.
Receives: Drug: APERNAVEC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety profile of APERNAVEC vector injection during the month following the injection

    To determine the safety profile with the number, the type and the severity of adverse events) occurring

    Measured: Day 1, Day 2, Day 5, Day 10 and 1 month after injection

Secondary outcomes (6)

  1. Safety profile of APERNAVEC vector injection during 6 months following the injection

    Number, type and severity of adverse events occurring between M1 and M3 and between M3 and M6.

    Measured: 1 month, 3 months and 6 months after injection

  2. Feasibility of the procedures

    Feasibility will be assessed through the number of patients for whom the injection is actually performed

    Measured: Day 0 (injection visit)

  3. local and systemic inflammatory reaction following injections

    Local and systemic inflammation and immune response following injection is a composite measure derived of 5 validated components: fever monitoring, change in the temperature of the treated limb (assessed with a thermal camera), levels of CRP, Fibrinogen, leukocyte ratios, lymphocyte subpopulations, level of Immunoglobulins panel, photographies ( to assess changes in the appearance of the treated limb) and volumetric variation of the affected limb. All of this components are essential and will be aggregated to arrive at one reported value : local and systemic inflammatory reaction following injections

    Measured: Day 0 (post injection), Day 1, Day 2, Day 10, 1 month, 3 months and 6 months after injection

  4. Efficacy of injections

    Efficacy will be explored through a composite measure derived from volumetric reduction of the affected limb, change in thickness and stiffness of the cutaneous and subcutaneous tissue of the fore-arm and arm assessed by ultrasound, analysis of modification in the lymphedema capillary network assessed by lymphofluoroscopy, by lymphoscintigraphy, by lymphoMRI, and change in quality of life assessed by the Lymphcol Arm and the SF36 questionnaires. All of this components are essential and will be aggregated to arrive at one reported value : efficacy of injections

    Measured: Day 1, Day 2, Day 10, 1 month, 3 months and 6 months after injection

  5. Pharmacokinetic of the APERNAVEC vector in the blood

    Pharmacokinetic of the APERNAVEC vector will be studied through dosage of the vector (p24 protein) in blood by ELISA

    Measured: Day 0, 4 hours post injection, 24h (Day 1), 48h (Day 2), Day 10 and1 month after injection

  6. plasma biobanking

    Constitute a plasma biobanking with blood samples

    Measured: Day 0, Day 10 and 1 month after injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07793656
Sponsor's protocol ID
RC31/24/0593
Other IDs
2024-520149-22-00
Acronym
LymphARN
Status last verified
Aug 2026
First submitted
11 Aug 2026
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing APERNAVEC in people with Secondary Lymphedema, run by University Hospital, Toulouse at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Charline DAGUZAN (05 61 77 84 90 ext. +33, daguzan.c@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety profile of APERNAVEC vector injection during the month following the injection (time frame: Day 1, Day 2, Day 5, Day 10 and 1 month after injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07793656.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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