NCT07269639

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

Golcadomide, Poseltinib, and Rituximab for Optimized Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma (Go-Pro-DLBCL)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single arm, open-label, phase I/II trial of Poseltinib in combination with golcadomide and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. Considering (1) the combination of BTK inhibitor, lenalidomide, and rituximab has demonstrated efficacy in R/R DLBCL, (2) golcadomide, a CELMoD, exhibits potent immunomodulatory activity compared to IMiDs such as lenalidomide, and (3) poseltinib is a potent, covalent BTK inhibitor with more than twice the selectivity for BTK compared to other BTK inhibitors, we anticipate that this combination will yield promising results in R/R DLBCL.

Conditions

• Large B-Cell Lymphoma (LBCL)

Interventions

Type	Name	Description
DRUG	Golcadomide + Poseltinib + Rituximab	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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-01
• Completion: 2028-09-01
• First posted: 2025-12-08
• Last updated: 2025-12-08

Locations

1 site across 1 country: South Korea