Clinical trial • Phase I • Oncology|Haematology

UBX-303061 for B-cell malignancies|Chronic lymphocytic leukaemia|Small lymphocytic lymphoma|Waldenström macroglobulinaemia|B-cell lymphoma

Phase I trial of UBX-303061 for B-cell malignancies|Chronic lymphocytic leukaemia|Small lymphocytic lymphoma|Waldenström macroglobulinaemia|B-cell lymphom…

Overview

Trial Therapeutic Area
Oncology|Haematology
Trial Disease
B-cell malignancies|Chronic lymphocytic leukaemia|Small lymphocytic lymphoma|Waldenström macroglobulinaemia|B-cell lymphoma
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
04-09-2024
First CTIS Authorization Date
11-01-2025

Trial design

Phase I trial across 4 sites in Poland.

Target Sample Size
52

Eligibility

Recruits 52 Vulnerable population selected; no details provided on consent or assent processes in the provided record..

Vulnerable Population
Vulnerable population selected; no details provided on consent or assent processes in the provided record.

Recruitment

Planned Sample Size
52
Recruitment Window Months
26
Consent Approach
No information provided on informed consent or assent in the record; vulnerable population selected but no age-specific consent/assent or languages described.

Geography

Total Number Of Sites
4
Total Number Of Participants
42

Poland

Earliest CTIS Part Ii Submission Date
12-12-2024
Latest Decision Or Authorization Date
25-08-2025
Processing Time Days
256
Number Of Sites
4
Number Of Participants
42

Sites

Site Name
Mtz Clinical Research Powered By Pratia
Department Name
MTZ Clinical Research Powered By Pratia
Contact Person Name
Iwona Hus
Contact Person Email
iwona.hus@pratia.com
Site Name
Pratia Hematologia Sp. z o.o.
Department Name
Pratia Hematologia Sp. z o.o.
Contact Person Name
Sebastian Grosicki
Contact Person Email
sgrosicki@wp.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
Medicover Integrated Clinical Services Sp. z o.o.
Contact Person Name
Dominik Chraniuk
Contact Person Email
d.chraniuk@naszlekarz.pl
Site Name
Aidport Sp. z o.o.
Department Name
Aidport Sp. z o.o.
Contact Person Name
Michal Kwiatek
Contact Person Email
michal.kwiatek@aidport.pl

Sponsor

Primary sponsor

Full Name
Ubix Therapeutics Inc.
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Korea, Republic of

Investigational products

Investigational Product Name
UBX-303061

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