mRNA Therapy to Restore Lymphatic Flow in Secondary Lymphedema

NCT07793656 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: RC31/24/05932024-520149-22-00
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Secondary Lymphedema

Keywords

secondary lymphedema; breast cancer; dual mRNA therapy

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (6)

• Safety profile of APERNAVEC vector injection during 6 months following the injection

  1 month, 3 months and 6 months after injection

• Feasibility of the procedures

  Day 0 (injection visit)

• local and systemic inflammatory reaction following injections

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

• Efficacy of injections

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

• Pharmacokinetic of the APERNAVEC vector in the blood

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

Study Arms (1)

Experimental group

EXPERIMENTAL

Patients with secondary lymphedema will be included to receive eight injections of the APERNAVEC (APELIN-VEGF-C FlashRNA® vector) at D0.

Drug: APERNAVEC

Interventions

APERNAVEC DRUG

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Flash Therapeutics: collaborator
• RNAlead: collaborator

Study Sites (1)

CHU de Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Julie MALLOIZEL-DELAUNAY, Dr

  Hôpital Rangueil, CHU Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charline DAGUZAN

CONTACT

05 61 77 84 90; daguzan.c@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)