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

NCT07774234 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-08-19

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Sonrotoclax

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.

BIOLOGICAL

Glofitamab

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.

DRUG

Gemcitabine (1000 mg/m2)

Gemcitabine 1000 mg/m² will be administered intravenously on Cycle 1 Day 2 and on Day 1 of Cycles 2-6.

DRUG

Oxaliplatin

Oxaliplatin 100 mg/m² will be administered intravenously on Cycle 1 Day 2 and on Day 1 of Cycles 2-6.

BIOLOGICAL

Obinutuzumab

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Ting Xu · The First Affiliated Hospital of Soochow University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-20
Primary Completion
2028-12-31
Completion
2030-08-20

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07774234 on ClinicalTrials.gov