Actively Recruiting
UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies
Led by Ubix Therapeutics, Inc. · Updated on 2025-11-19
94
Participants Needed
11
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of UBX-303061 in patients with relapsed/refractory B-cell malignancies.
CONDITIONS
Official Title
UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Capable of giving signed informed consent
- Age 18 years or older
- ECOG performance status 0, 1, or 2
- For Phase Ia: Relapsed/refractory B-cell malignancies (CLL/SLL, DLBCL, FL, MCL, WM, or MZL) with at least 2 prior therapies or no available treatment options
- For Phase Ib: Relapsed/refractory B-cell malignancies with at least 2 prior therapies or no available treatment options, fitting into CLL/SLL, DLBCL, MCL, FL, WM, or MZL groups
- Evaluable or measurable disease based on tumor type criteria
- Adequate organ and bone marrow function
You will not qualify if you...
- Systemic antineoplastic or experimental therapy within 3 weeks or 5 half-lives before first study dose
- Tyrosine kinase inhibitor therapy within 5 half-lives before first study dose
- Unconjugated monoclonal antibody therapies within 6 weeks before first study dose
- Autologous stem cell rescue within 100 days prior to first study dose
- Allogeneic stem cell transplant within 6 months prior to first study dose
- Active graft-versus-host disease or on anti-GVHD treatment/prophylaxis
- History of CAR-T therapy within 100 days before study drug start
- Any immunotherapy within 4 weeks before first study dose
- Less than 5 times the half-life from last chemotherapy/experimental therapy to first study dose
- Previous exposure to BTK degradation therapy
- Malignant disease other than the one being treated
- Radiotherapy within 2 weeks before first study dose
- Known hypersensitivity to BTK degraders or ingredients
- Impaired cardiac function or significant cardiac disease
- History of severe bleeding disorders or known/suspected autoimmune disease
- Major surgery within 4 weeks before first study dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
2
Gabrail Cancer Center
Canton, Oklahoma, United States, 44718
Actively Recruiting
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
4
MICS Centrum Medyczne Toruń
Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
Not Yet Recruiting
5
Pratia, MTZ Clinical Research
Warsaw, Mazowieckie Voivodeship, Poland, 02-172
Not Yet Recruiting
6
Pratia, Oncology Katowice
Katowice, Silesian Voivodeship, Poland, 40-519
Not Yet Recruiting
7
AidPort
Grodzisk Wielkopolski, Wielkopolskie Voivodeship, Poland, 62-065
Not Yet Recruiting
8
Asan Medical Center
Seoul, Seoul, South Korea, 05505
Actively Recruiting
9
Samsung Medical Center
Seoul, Seoul, South Korea, 06351
Actively Recruiting
10
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seoul, South Korea, 06591
Actively Recruiting
11
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, Seoul, South Korea, 07345
Actively Recruiting
Research Team
P
Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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