Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
72
Countries
2
Sites
8
T-cell Non-Hodgkin Lymphoma
Key facts
- Sponsor
- Kyowa Kirin Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-04-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-522523-96-00
- ClinicalTrials.gov
- NCT07192471
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
T-cell Non-Hodgkin Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | PT | 10011677 | Cutaneous T-cell lymphoma | 100000004864 |
| 28.0 | HLGT | 10025321 | Lymphomas non-Hodgkin´s T-cell | 10029104 |
| 28.0 | PT | 10034623 | Peripheral T-cell lymphoma unspecified | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Kyowa Kirin Inc.
- Sponsor organisation
- Kyowa Kirin Inc.
- Address
- 510 Carnegie Center Suite 600
- City
- Princeton
- Postcode
- 08540-6241
- Country
- United States
Scientific contact point
- Organisation
- Kyowa Kirin Inc.
- Contact name
- Corporate Communications
Public contact point
- Organisation
- Kyowa Kirin Inc.
- Contact name
- Corporate Communications
Locations
2 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 17 | 4 |
| Spain | Authorised, recruitment pending | 17 | 4 |
| Rest of world
United States
|
— | 38 | — |
Investigational sites
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
ITL004: UOC Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
ITL003: Oncologia Medica ed Ematologia, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
ITL002: Ematologia Universitaria, Corso Bramante 88, 10126, Turin
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
ITL001: Ematologia, Piazza Oms 1, 24127, Bergamo
Clinica Universidad De Navarra
ESP001: Hematology and Hemotherapy, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Clinic De Barcelona
ESP002: Hematología, Calle Villarroel 170, 08036, Barcelona
Institut Catala D'oncologia
ESP003: Hematologia, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Clinica Universidad De Navarra
ESP004: Hematología, Calle Marquesado De Santa Marta 1, 28027, Madrid
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-08 | Spain | Acceptable with conditions 2026-03-30
|
2026-04-01 |