Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
30
Countries
1
Sites
2
Relapsed or refractory CD20+ diffuse large B-cell lymphoma, mantle cell lymphoma or indolent lymphoma
Key facts
- Sponsor
- Uppsala Universitet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 2 May 2024 → ongoing
- Decision date (initial)
- 2024-09-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511844-18-00
- EudraCT number
- 2022-004157-31
- ClinicalTrials.gov
- NCT06002659
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed or refractory CD20+ diffuse large B-cell lymphoma, mantle cell lymphoma or indolent lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10065856 | Non-Hodgkin's lymphoma unspecified histology indolent | 100000004864 |
| 20.0 | PT | 10061275 | Mantle cell lymphoma | 100000004864 |
| 21.0 | PT | 10012818 | Diffuse large B-cell lymphoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Uppsala Universitet
- Sponsor organisation
- Uppsala Universitet
- Address
- P. O. Box 256
- City
- Uppsala
- Postcode
- 751 05
- Country
- Sweden
Scientific contact point
- Organisation
- Uppsala Universitet
- Contact name
- Di Yu
Public contact point
- Organisation
- Uppsala Universitet
- Contact name
- Gunilla Enblad
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 30 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Sweden | 2024-05-02 | 2024-05-02 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-22 | Sweden | Acceptable with conditions 2024-09-02
|
2024-09-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-25 | Sweden | Acceptable 2025-07-21
|
2025-07-21 |