Validation of in Vitro Method for Anti-MCPyV Immunotherap... | NCT06780475

Studies
Validation of in Vitro Method for Anti-MCPyV Immunotherapy on Patients With Cutaneous Merkel Cell Carcinoma

NCT06780475

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Recruiting

Last Update Posted

Nov 19, 2025Actual

Enrollment

15Estimated

Phase

Not provided

Conditions

Merkel Cell Carcinoma of Skin

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2024-A00643-44	Registry Identifier	IDRCB

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 27, 2025Actual

Primary Completion Date

May 2027Estimated

Completion Date

May 2027Estimated

First Submitted Date

Jan 13, 2025

First Submission Date that Met QC Criteria

Jan 13, 2025

First Posted Date

Jan 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2025

Last Update Posted Date

Nov 19, 2025Actual

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to test and validate in vitro a cell therapy approach for MCPyV+ Merkel Cell Carcinoma patients.

Detailed Description

The aim of the study is to test and validate in vitro a cell therapy approach for MCPyV+ Merkel Cell Carcinoma patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anti-MCPyV functionality	Anti-MCPyV functionality, including cytotoxicity, of T cells obtained after in vitro culture.	Day 0 and Day 4

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients >= 18 years old;
Diagnosed with Merkel cell carcinoma of skin, ongoing for local treatment, systemic treatment, complementary treatment or an active follow-up;
Informed for the study and no-opposed for participation;
Affiliated with a social security scheme or in an equivalent situation.

Exclusion Criteria:

Patients ongoing another interventional clinical trial;
Patients under guardianship or trusteeship;
Pregnancy or breastfeed;
Patients refusal.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients of Merkel cell carcinoma of skin, ongoing for local treatment, systemic treatment, complementary treatment or with an active follow-up beside dermatologist.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Astrid Blom, MD	Contact	+33 (01) 49 09 44 82		astrid.blom@aphp.fr
Yassine Taoufik, MD, PhD	Contact			yassine.taoufik@aphp.fr

Overall Officials

Name	Affiliation	Role
Astrid Blom, MD	Dermato-oncology Department, Ambroise Paré Hospital, APHP	Principal Investigator
Yassine Taoufik, MD, PhD	U1186 INSERM, PAUL BROUSSE Hospital, APHP	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dermato-oncology Department, Ambroise Paré Hospital, APHP	Recruiting	Boulogne-Billancourt		92100	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided