Clinical trial • Phase III • Immunology|Neurology|Dermatology

CD19-targeted CAR iNK cells for Systemic lupus erythematosus | Lupus nephritis | Idiopathic inflammatory myopathy | Diffuse cutaneous systemic sclerosis

Phase III trial of CD19-targeted CAR iNK cells for Systemic lupus erythematosus | Lupus nephritis | Idiopathic inflammatory myopathy | Diffuse cutaneous s…

Overview

Trial Therapeutic Area
Immunology|Neurology|Dermatology
Trial Disease
Systemic lupus erythematosus | Lupus nephritis | Idiopathic inflammatory myopathy | Diffuse cutaneous systemic sclerosis
Trial Stage
Phase III
Drug Modality
Cell therapy

Key dates

Initial CTIS Submission Date
06-12-2024
First CTIS Authorization Date
16-04-2025

Trial design

None/Not specified-controlled Phase III trial across 6 sites in France, Germany, Italy.

Comparator
None/Not specified
Target Sample Size
24

Recruitment

Planned Sample Size
24
Recruitment Window Months
9

Geography

Total Number Of Sites
6
Total Number Of Participants
16

France

Latest Decision Or Authorization Date
21-11-2025
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service de Rhumatologie
Principal Investigator Name
Alain Meyer
Principal Investigator Email
alain.meyer1@chru-strasbourg.fr
Contact Person Name
Alain Meyer
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service d’Immunologie Clinique
Principal Investigator Name
Alain Meyer
Principal Investigator Email
alain.meyer1@chru-strasbourg.fr
Contact Person Name
Alain Meyer
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Département de médecine interne
Principal Investigator Name
Gregory Pugnet
Principal Investigator Email
pugnet.g@chu-toulouse.fr
Contact Person Name
Gregory Pugnet
Contact Person Email
pugnet.g@chu-toulouse.fr

Germany

Latest Decision Or Authorization Date
19-12-2025
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Johannes Wesling Klinikum Minden
Department Name
Department of rheumatologyand clinical immunology
Principal Investigator Name
Gunter Aßmann
Principal Investigator Email
gunter.assmann@muehlenkreiskliniken.de
Contact Person Name
Gunter Aßmann

Italy

Latest Decision Or Authorization Date
17-11-2025
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Rheumatology
Principal Investigator Name
Maria Antonietta D’Agostino
Contact Person Name
Maria Antonietta D’Agostino
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Hematology and Cell Therapy
Principal Investigator Name
Emanuele Angelucci
Principal Investigator Email
Emanuele.angelucci@hsanmartino.it
Contact Person Name
Emanuele Angelucci

Sponsor

Primary sponsor

Full Name
Century Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
CNTY-101
Active Substance
CD19-targeted CAR iNK cells
Modality
Cell therapy

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