Sonrotoclax, Glofitamab, Gemcitabine, and Oxaliplatin for Relapsed or Refractory Large B-Cell Lymphoma

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT07774234
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • High-grade B-cell Lymphoma
  • Large B-Cell Lymphoma (LBCL)

Eligibility Criteria

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

Interventions

  • Sonrotoclax — DRUG
    Sonrotoclax will be administered orally. In Cycle 1, participants will receive 80 mg on Day 3, 160 mg on Day 4, and 320 mg once daily on Days 5-9. During Cycles 2-12, sonrotoclax will be administered at 320 mg once daily on Days 1-5 of each 21-day cycle.
  • Glofitamab — BIOLOGICAL
    Glofitamab will be administered intravenously using step-up dosing: 2.5 mg on Cycle 1 Day 8, 10 mg on Cycle 1 Day 15, and 30 mg on Day 1 of Cycles 2-12.
  • Gemcitabine (1000 mg/m2) — DRUG
    Gemcitabine 1000 mg/m² will be administered intravenously on Cycle 1 Day 2 and on Day 1 of Cycles 2-6.
  • Oxaliplatin — DRUG
    Oxaliplatin 100 mg/m² will be administered intravenously on Cycle 1 Day 2 and on Day 1 of Cycles 2-6.
  • Obinutuzumab — BIOLOGICAL
    Obinutuzumab 1000 mg will be administered intravenously once on Cycle 1 Day 1 as pretreatment before glofitamab administration to reduce the risk of cytokine release syndrome.

Study Details

This investigator-initiated, single-center, single-arm, open-label Phase II study will evaluate the efficacy and safety of sonrotoclax in combination with glofitamab, gemcitabine, and oxaliplatin in adults with relapsed or refractory large B-cell lymphoma. Participants will receive six 21-day cycles of glofitamab, gemcitabine, oxaliplatin, and sonrotoclax, followed by six 21-day cycles of glofitamab and sonrotoclax. The primary objective is to evaluate the complete response rate at the end of Cycle 6 according to the Lugano 2014 criteria. The study plans to enroll 39 participants.

Key Dates

First listed
Aug 19, 2026
Start date
Aug 20, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Aug 20, 2030

Study Design

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

Arms

  • Experimental: Sonrotoclax + Glofitamab + GemOx
    Participants will receive 12 treatment cycles, each lasting 21 days. During Cycles 1-6, participants will receive sonrotoclax, glofitamab, gemcitabine, and oxaliplatin. During Cycles 7-12, participants will receive sonrotoclax and glofitamab. Obinutuzumab will be administered once on Cycle 1 Day 1 as pretreatment before glofitamab step-up dosing.

Primary Outcome Measure

Complete Response Rate (CRR) at the End of Induction Treatment [ Time Frame: At the end of Cycle 6 (approximately Week 18) ]

Central Contacts

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