Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
94
Countries
1
Sites
4
B-cell malignancies
Key facts
- Sponsor
- Ubix Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Decision date (initial)
- 2025-01-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
B-cell malignancies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10003912 | B-cell small lymphocytic lymphoma refractory | 100000004864 |
| 21.1 | PT | 10008962 | Chronic lymphocytic leukaemia refractory | 100000004864 |
| 21.1 | PT | 10003911 | B-cell small lymphocytic lymphoma recurrent | 100000004864 |
| 21.0 | PT | 10047805 | Waldenstrom's macroglobulinaemia refractory | 100000004864 |
| 21.0 | PT | 10047804 | Waldenstrom's macroglobulinaemia recurrent | 100000004864 |
| 21.1 | PT | 10008961 | Chronic lymphocytic leukaemia recurrent | 100000004864 |
| 21.0 | PT | 10003903 | B-cell lymphoma refractory | 100000004864 |
| 21.0 | PT | 10003902 | B-cell lymphoma recurrent | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ubix Therapeutics Inc.
- Sponsor organisation
- Ubix Therapeutics Inc.
- Address
- 7/1401 Beobwonro11-Gil
- City
- Songpa
- Postcode
- 05836
- Country
- Korea, Republic of
Scientific contact point
- Organisation
- Ubix Therapeutics Inc.
- Contact name
- SunYoung Cho
Public contact point
- Organisation
- Ubix Therapeutics Inc.
- Contact name
- SunYoung Cho
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Authorised, recruitment pending | 42 | 4 |
| Rest of world
United States, Korea, Republic of
|
— | 52 | — |
Investigational sites
Mtz Clinical Research Powered By Pratia
MTZ Clinical Research Powered By Pratia, Ul. Gładka 22, 02-172, Warsaw
Aidport Sp. z o.o.
Aidport Sp. z o.o., Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
Medicover Integrated Clinical Services Sp. z o.o.
Medicover Integrated Clinical Services Sp. z o.o., Ul. Stefana Batorego 18-22, 87-100, Torun
Pratia Hematologia Sp. z o.o.
Pratia Hematologia Sp. z o.o., Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-04 | Poland | Acceptable with conditions 2025-01-08
|
2025-01-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-20 | Poland | Acceptable 2025-08-18
|
2025-08-25 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-24 | Poland | Acceptable 2025-08-18
|
2025-09-24 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-14 | Poland | Acceptable 2026-02-12
|
2026-02-16 |