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UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies | Clinical Trials | Clareo Health

RECRUITINGPHASE1

UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies

A Phase Ia/Ib, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic of UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies

NCT06590961•Ubix Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Capable of giving signed informed consent
•Age ≥18 years
•ECOG performance status ≤2.
•Phase Ia (dose-escalation part only): Subjects with relapsed and/or refractory B-cell malignancies (CLL/SLL, DLBCL, FL, MCL, WM or MZL) who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion.
•Phase Ib (dose-expansion only): Subjects with relapsed and/or refractory B-cell malignancies who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion, and fit into one of the following groups: CLL/SLL or DLBCL or MCL or FL, WM, MZL
•All subjects must have evaluable or measurable disease based on the appropriate tumor type criteria
•Adequate organ and bone marrow function

Exclusion Criteria

•For subjects with lymphoma:
•* Systemic antineoplastic therapy or any experimental therapy within 3 weeks or 5 half-lives, whichever is shorter, before the first dose of study treatment.
•* Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment.
•* Unconjugated monoclonal antibody therapies \<6 weeks before the first dose of study treatment.
•* Subjects that have undergone autologous stem cell rescue within 100 days prior to the first dose of study treatment.
•* Subjects that have undergone allogeneic stem cell transplant within 6 months prior to the first dose of study treatment.
•* Subjects with active graft-versus-host disease (GVHD) or on anti-GVHD treatment or prophylaxis.
•* History of chimeric antigen receptor T cell (CAR-T) therapy within 100 days prior to start of study drug.
•* Any immunotherapy within 4 weeks of first dose of study drug.
•* The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drug is \<5 times the t1/2 of the previously administered agent(s).
+7 more criteria

Locations (11)

University of Michigan

Ann Arbor, Michigan, United States

Gabrail Cancer Center

Canton, Oklahoma, United States

MD Anderson Cancer Center

Houston, Texas, United States

MICS Centrum Medyczne Toruń

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Pratia, MTZ Clinical Research

Warsaw, Mazowieckie Voivodeship, Poland

Pratia, Oncology Katowice

Katowice, Silesian Voivodeship, Poland

AidPort

Grodzisk Wielkopolski, Wielkopolskie Voivodeship, Poland

Asan Medical Center

Seoul, Seoul, South Korea

Samsung Medical Center

Seoul, Seoul, South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Seoul, South Korea

Key Dates

Start Date

February 20, 2025

Primary Completion Date

August 1, 2027

Completion Date

August 1, 2027

Last Updated

November 19, 2025

Enrollment

ESTIMATED participants

Conditions

Relapsed/Refractory B-cell Malignancies

Interventions

UBX-303061

DRUG

Contacts

Project Manager

CONTACT

+82 (2) 6334 2475 ubix_co@ubixtrx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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