New Therapeutic Target for Toxic Epidermal Necrolysis (TEN) Using Anti-CD38+ Monoclonal Antibodies.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-29

Study Completion Date

2029-04-29

Brief Summary

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Toxic Epidermal Necrolysis (TEN) are rare diseases that are dermatologic emergencies characterized by widespread epidermal necrosis and sloughing of skin. A hundred patients are affected each year in France. The main symptom is bullous and skin detachment \> 10% which gradually progresses to extensive necrosis of the 100% BSA epidermis. The mortality rate is around 15-20% due to visceral inflammatory injuries and serious bacterial infections. The morbidity is also very important (92% at 1 year), especially ophthalmologic with high risk of blindness. There is currently no effective treatment.

Our team recently demonstrated that the severity of the disease correlates with the quantity and quality of CD8+ T lymphocytes which are activated in the active phase of disease. An activation marker has been identified, the CD38 receptor, which is very strongly expressed on the T clones responsible for the disease in the skin or blood of patients The CD38 receptor is the target of several commercial therapeutic antibodies, including DARATUMUMAB, which is currently used for the treatment of myeloma. DARATUMUMAB is a depleting antibody that eliminates cells strongly expressing this receptor.

The hypothesis is that a single intravenous infusion of DARATUMUMAB upon hospital admission of a patient with drug-induced NET would eliminate pathogenic T cells, thereby slowing disease progression, severity (% BSA with skin detachment, mortality rate) and sequelae.

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Detailed Description

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Conditions

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Toxic Epidermal Necrolysis Immunotherapy Cutaneous Adverse Drug Reactions (CADR)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a prospective, single-center, open-label phase I/II study using an optimal two-stage SIMON-type design for efficacy/tolerance evaluation (Simon, 1989), with an additional stage for tolerance evaluation alone... :

1. After the first three inclusions, and two months of follow-up, a safety analysis with an opinion from the Independent Study Monitoring Board (DSMB) and an efficacy analysis (Simon's plan) will be carried out. If the rules allow (at least one patient with cessationof progression and a positive opinion from the DSMB concerning safety), 3 new patients will be included.
2. After the first 6 inclusions and two months' follow-up, a safety analysis with a DSMB opinion will be carried out. If the DSMB opinion is favorable, 3 additional patients will be included.

The 2-month follow-up period is sufficient for the collection of clinico-biological criteria of interest.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

Single intravenous infusion of DARATUMUMAB 16 mg/kg body weight.

Group Type EXPERIMENTAL

DARATUMUMAB (DARZALEX®)

Intervention Type DRUG

A single injection of DARZALEX 16 mg/kg body weight administered by intravenous infusion (day 1) in addition to standard symptomatic treatment of NET until re-epidermalization.

Interventions

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DARATUMUMAB (DARZALEX®)

A single injection of DARZALEX 16 mg/kg body weight administered by intravenous infusion (day 1) in addition to standard symptomatic treatment of NET until re-epidermalization.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult, over 18 years old, with drug-induced SJS/NET, proven or very strongly suspected (indirect argument of certainty) and confirmed by the evaluator.
* SJS or NET or overlap syndrome evolving for less than 7 days prior to inclusion and with a progression of the detachment or rash observed within 48 hours prior to DARATUMUMAB treatment.
* Negative hepatitis B screening (HBs, anti HBs and HBc).
* The patient (or a trusted support person, family member, or close relative in case of emergency) must be capable of understanding the objectives of the trial and must have given free, informed, and express consent.
* Patient affiliated to the Social Security system or benefiting from a similar system.
* Negative beta HCG pregnancy test for women of childbearing potential and agreement to use effective contraception during the study and up to 3 months after stopping DARATUMUMAB treatment.

Exclusion Criteria

* Patient with Lyell syndrome induced by immunotherapy.
* Known hypersensitivity to the active substance (DARZALEX) or to one of the excipients (L-histidine, L-histidine hydrochloride monohydrate, L-methionine, Polysorbate 20 Sorbitol -E420).
* Patient with known hereditary fructose intolerance (HFI).
* Patient with known history of chronic obstructive pulmonary disease (COPD).
* Patient admitted with septic shock.
* PMNs \< 1,500 /mm3 on CBC at inclusion visit.
* Pregnant or breast-feeding women.
* Patient under protective measures (safeguard, curatorship, guardianship) or deprived of liberty.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No