Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
200
Countries
4
Sites
15
Relapsed/Refractory Multiple Myeloma
Key facts
- Sponsor
- IGI Therapeutics S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 14 Aug 2025 → ongoing
- Decision date (initial)
- 2025-06-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507071-21-01
- ClinicalTrials.gov
- NCT05862012
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/Refractory Multiple Myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10067095 | Multiple myeloma progression | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
IGI Therapeutics S.A.
- Sponsor organisation
- IGI Therapeutics S.A.
- Address
- Rue Du Puits-Godet 8
- City
- Neuchatel
- Postcode
- 2000
- Country
- Switzerland
Scientific contact point
- Organisation
- IGI Therapeutics S.A.
- Contact name
- Biologics Manufacturing/ Process Sciences entity
Public contact point
- Organisation
- IGI Therapeutics S.A.
- Contact name
- Biologics Manufacturing/ Process Sciences entity
Locations
4 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 25 | 5 |
| Italy | Authorised, recruiting | 15 | 3 |
| Norway | Ongoing, recruiting | 20 | 1 |
| Spain | Ongoing, recruiting | 25 | 6 |
| Rest of world
Japan, United States, United Kingdom, India, Australia
|
— | 115 | — |
Investigational sites
Centre Hospitalier Universitaire De Poitiers
Hematology, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Lille
Maladies du sang, Rue Michel Polonowski, 59000, Lille
Hopital Saint Antoine
Hematology, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Centre Hospitalier Universitaire De Nantes
Hematology, 1 Place Alexis Ricordeau, 44000, Nantes
Assistance Publique Hopitaux De Paris
Haematology, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
S.C. Hematology, Via Francesco Sforza 28, 20122, Milan
Humanitas Mirasole S.p.A.
U.O di Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
U.O.C. Ematologia, Piazzale Spedali Civili 1, 25123, Brescia
Hospital Universitario Fundacion Jimenez Diaz
Hematology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Clinica Universidad De Navarra
Hematology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Hm Sanchinarro
Hematology, Calle Ona 10, 28050, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-08-14 | 2025-09-26 | |||
| Italy | 2025-09-26 | ||||
| Norway | 2025-08-26 | 2025-09-24 | |||
| Spain | 2025-08-29 | 2025-11-27 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-28 | France | Acceptable 2025-06-16
|
2025-06-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-05 | France | Acceptable 2025-09-04
|
2025-09-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-18 | France | Acceptable 2025-11-26
|
2025-11-26 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-21 | France | Acceptable 2026-04-07
|
2026-04-07 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-06-01 | France | Acceptable 2026-04-07
|
2026-06-01 |