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NCT06590961 | RECRUITING | Relapsed/Refractory B-cell Malignancies

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

Ubix Therapeutics, Inc.

Brief 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.

Condition or disease

Relapsed/Refractory B-cell Malignancies

Intervention/treatment

UBX-303061

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 94 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-02-20
Estimated Primary Completion Date : 2027-08
Estimated Study Completion Date : 2027-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key 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
  • Key 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).
    • * Previously exposed to BTK degradation therapy
    • * Malignant disease, other than that being treated in this study.
    • * Radiotherapy within 2 weeks of the first dose of study treatment
    • * Known hypersensitivity to BTK degraders or any of the ingredients.
    • * Impaired cardiac function or clinically significant cardiac disease
    • * Subjects with history of severe bleeding disorders and known/suspected other autoimmune disease
    • * Major surgery within 4 weeks of the first dose of study treatment
    • UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies

    Location Details

    NCT06590961

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, road cancer

    University of Michigan

    Ann Arbor, road cancer, United States, 48109

    RECRUITING

    United States, Oklahola

    Gabrail Cancer Center

    Canton, Okholohan, United States, 44718

    RECRUITING

    United States, Texas

    MD Anderson Cancer Center

    Houston, Texas, United States, 77030

    NOT YET RECRUITING

    Poland, Kuyavian-Pomeranian Voivodeship

    MICS Medical Center Toruń

    Grandchild, Kuyavian-Pomeranian Voivodeship, Poland, 87-100

    NOT YET RECRUITING

    Poland, Mazowieckie Voivodeship

    Pratia, MTZ Clinical Research

    Warsaw, Mazowieckie Voivodeship, Poland, 02-172

    NOT YET RECRUITING

    Poland, Silesian Voivodeship

    Pratia, Oncology Katowice

    Katowice, Silesian Voivodeship, Poland, 40-519

    NOT YET RECRUITING

    Poland, Wielkopolskie Voivodeship

    adport

    Grodzisk Wielkopolski, Wielkopolskie Voivodeship, Poland, 62-065

    RECRUITING

    South Korea, Seoul

    Asan Medical Center

    Seoul, Seoul, South Korea, 05505

    RECRUITING

    South Korea, Seoul

    Samsung Medical Center

    Seoul, Seoul, South Korea, 06351

    RECRUITING

    South Korea, Seoul

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

    Seoul, Seoul, South Korea, 06591

    RECRUITING

    South Korea, Seoul

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

    Seoul, Seoul, South Korea, 07345