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

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
Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
Ophthalmology Building
Contact Person Name
Daniela Fodor

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
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

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

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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