Clinical trial • Phase I • Musculoskeletal
CLN-978 for Systemic lupus erythematosus
Phase I trial of CLN-978 for Systemic lupus erythematosus. open-label. 28 participants.
Overview
- Trial Therapeutic Area
- Musculoskeletal
- Trial Disease
- Systemic lupus erythematosus
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 15-08-2025
- First CTIS Authorization Date
- 25-11-2025
Trial design
open-label Phase I trial across 11 sites in Bulgaria, Romania, France and others.
- Open Label
- Yes
- Target Sample Size
- 28
Recruitment
- Planned Sample Size
- 28
- Recruitment Window Months
- 49
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 44
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 15-08-2025
- Latest Decision Or Authorization Date
- 25-11-2025
- Processing Time Days
- 102
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Multispecialty hospital for active treatment Sveta Sofia EOOD
- Department Name
- Internal Diseases
- Contact Person Name
- Mariana Goycheva
- Contact Person Email
- mariana.goycheva.ext@arensia-em.com
Romania
- Earliest CTIS Part Ii Submission Date
- 05-12-2025
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 101
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Arensia Clinics S.R.L.
- Department Name
- 3rd Floor, Wards 1, 2, 3, 4, 5, 6 and 7
- Contact Person Name
- Mihai Abobului
- Contact Person Email
- mihai.abobului.ext@arensiaem.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Cluj
- Department Name
- Ophthalmology Building
- Contact Person Name
- Daniela Fodor
- Contact Person Email
- daniela.fodor.ext@arensiaem.com
France
- Earliest CTIS Part Ii Submission Date
- 19-01-2026
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 109
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Service Medecine Interne
- Contact Person Name
- Martin KILLIAN
- Contact Person Email
- Martin.Killian@chu-st-etienne.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Service Medecine Interne et immunologie clinique
- Contact Person Name
- Gregory PUGNET
- Contact Person Email
- pugnet.g@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service Medecine Interne
- Contact Person Name
- Antoine NEEL
- Contact Person Email
- Antoine.neel@chu-nantes.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 19-01-2026
- Latest Decision Or Authorization Date
- 08-04-2026
- Processing Time Days
- 79
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Medizinische Klinik V/ Sektion Rheumatologie
- Contact Person Name
- Hanns-Martin Lorenz
- Contact Person Email
- hanns-martin.lorenz@med.uni-heidelberg.de
Spain
- Earliest CTIS Part Ii Submission Date
- 28-01-2026
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 63
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Hospital Quironsalud Infanta Luisa
- Department Name
- Rheumatology
- Contact Person Name
- Juan Miguel Sanchez Burson
- Contact Person Email
- uan.sanchezburson@arensiaem.com
Poland
- Earliest CTIS Part Ii Submission Date
- 02-02-2026
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 86
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Malopolskie Centrum Kliniczne
- Department Name
- Nie dotyczy
- Contact Person Name
- Ewa Zimmer-Satora
- Contact Person Email
- biuro@mck-krakow.pl
- Site Name
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
- Department Name
- Nie dotyczy
- Contact Person Name
- Brygida Kwiatkowska
- Contact Person Email
- cwbk@spartanska.pl
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o.
- Department Name
- MICS Centrum Medyczne Warszawa, Chłodna
- Contact Person Name
- Małgorzata Gryka-Marton
- Contact Person Email
- marta.jeka@medicover.com
Sponsor
Primary sponsor
- Full Name
- Cullinan Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- CLN-978
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