Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
140
Countries
2
Sites
8
Advanced B cell Non-Hodgkin Lymphomas
Key facts
- Sponsor
- Iksuda Therapeutics Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Jan 2025 → ongoing
- Decision date (initial)
- 2024-09-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512415-45-00
- WHO UTN
- U1111-1307-6884
- ClinicalTrials.gov
- NCT05365659
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced B cell Non-Hodgkin Lymphomas
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Iksuda Therapeutics Limited
- Sponsor organisation
- Iksuda Therapeutics Limited
- Address
- The Biosphere, Draymans Way, Newcastle Helix Draymans Way Newcastle Helix
- City
- Newcastle Upon Tyne
- Postcode
- NE4 5BX
- Country
- United Kingdom
Scientific contact point
- Organisation
- Iksuda Therapeutics Limited
- Contact name
- David M. Browning
Public contact point
- Organisation
- Iksuda Therapeutics Limited
- Contact name
- David M. Browning
Locations
2 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 40 | 4 |
| Spain | Ongoing, recruiting | 40 | 4 |
| Rest of world
Canada, Australia, United States
|
— | 60 | — |
Investigational sites
Istituto Europeo Di Oncologia S.r.l.
Oncoematologia, Via Giuseppe Ripamonti 435, 20141, Milan
Humanitas Mirasole S.p.A.
Sezione Linfomi e Mieloma, Via Alessandro Manzoni 56, 20089, Rozzano
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Ematologia, Strada Provinciale 142 Km 3,95, 10060, Candiolo
Ospedale San Raffaele S.r.l.
Unità di Ricerca Clinica sui Linfomi - L’Unità di Ematologia, Via Olgettina 60, 20132, Milan
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Quironsalud Madrid
Hematology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
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 |
|---|---|---|---|---|---|
| Italy | 2025-01-14 | 2025-02-19 | |||
| Spain | 2025-01-20 | 2025-12-03 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-23 | Italy | Acceptable 2024-09-11
|
2024-09-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-18 | Italy | Acceptable 2024-11-25
|
2024-11-28 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-07 | Italy | Acceptable 2024-11-25
|
2025-02-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-30 | Italy | Acceptable 2026-01-20
|
2026-01-22 |