Not Yet RecruitingPhase 1/2

Golcadomide, Poseltinib, and Rituximab for Relapsed/Refractory Diffuse Large B-cell Lymphoma

South Korea20 participantsStarted 2026-01-01

Plain-language summary

This trial is a proof-of-concept, pilot study, phase I/II clinical trial aimed at generating preliminary data on the combination of golcadomide, poseltinib, and rituximab.

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. Subject is ≥ 19 years of age at the time of signing the informed consent form (CRF).
✓. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
✓. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
✓. Subject has histologically confirmed (per local evaluation) diagnosis of aggressive large B-cell lymphoma according to 2022 WHO classification, specifically:
✓. Relapsed or refractory disease following at least 1 prior line of therapy (must include an anthracycline-based treatment), and ineligible for hematopoietic stem cell transplantation.
✓. Subjects must have measurable disease defined by at least one fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and one bi-dimensionally measurable (\> 1.5 cm in longer diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification.
✓. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
✓. Subject must have the following laboratory values:

Exclusion criteria

✕. Subject who has had prior treatment with golcadomide.
✕. Subject who has had prior treatment with BTK inhibitor.
✕. Subject has life expectancy ≤ 2 months.
✕. Subject has received any of the following:
✕. Subject has previously received solid organ transplantation.
✕. Subject has undergone allogeneic SCT within 1 year prior to initiating study treatment or autologous SCT within 3 months prior to initiating study treatment.
✕. Subject has any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma, primary cutaneous DLBCL-leg type, Grade 3b FL, ALK-positive large B-cell lymphoma, primary effusion lymphoma, or Burkitt lymphoma are excluded.
✕. Subject has active central nervous system (CNS) involvement by lymphoma

What they're measuring

Overall response rate (ORR)

Timeframe: The evaluation time frame is from baseline up to 18 months.

Trial details

NCT IDNCT07269639

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-01

Contact for this trial

Ja Min Byun, MD, PhD

+82-2-2072-7217 jaminbyun@snu.ac.kr

View on ClinicalTrials.gov More Large B-Cell Lymphoma (LBCL) trials