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

Sponsor
Seoul National University Hospital
Study ID
NCT07269639
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Large B-Cell Lymphoma (LBCL)

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Golcadomide + Poseltinib + Rituximab — DRUG
    Participants will receive 0.4 mg of golcadomide once daily for 14 consecutive days for 18 cycles in 28-day cycles. The first 6 cycles will be administered in combination with rituximab and poseltinib, while the remaining 12 cycles will be conducted with poseltinib alone. During the maintenance period (Cycles 7-18), the first day of study treatment administration with golcadomide is designated as Day 1 of each cycle. Rituximab can be administered with or up to 2 hours after the morning dose of golcadomide in the fed or fasted state. For Cycles 1-6, the first day of study treatment administration with rituximab is designated as Day 1 of each cycle. Rituximab will be administered as an IV infusion at a dose of 375 mg/m2 on Days 1, 8, 15, and 22 of Cycle 1, and Day 1 of Cycles 2-6. Poseltinib is administered orally twice daily, approximately every 12 hour. Part 1 (safety cohort) of the study will be conducted in up to approximately 9 participants to select the optimal RP2D of poseltinib.

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
Nov 2025
Primary completion
Dec 1, 2027
Completion
Sep 1, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm
    golcadomide + poseltinib + rituximab (GoPro)

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: The evaluation time frame is from baseline up to 18 months. ]

Central Contacts

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