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NOT YET RECRUITING
NCT07888621
PHASE2

Glofitamab Plus Gemcitabine and Oxaliplatin (GemOx) in Relapsed or Refractory Primary and Secondary Central Nervous System Lymphoma

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

This study is being done to find out whether the combination of glofitamab, gemcitabine and oxaliplatin (GemOx) works and is safe in people whose lymphoma has come back or has not responded to previous treatment and has spread to the central nervous system (the brain, spinal cord, cerebrospinal fluid and/or eye). Central nervous system lymphoma is difficult to treat, and there is no agreed standard treatment once it returns. Glofitamab is a bispecific antibody that helps the body's own immune T cells attach to and destroy lymphoma B cells.All participants will receive the study treatment every 3 weeks for up to 6 treatment cycles, followed by maintenance treatment in participants whose lymphoma shrinks or disappears. The main goal is to measure how many participants respond to the treatment; the study will also measure how long responses last and what side effects occur.

Official title: A Multicenter, Open-Label, Single-Arm, Prospective Clinical Study of Glofitamab Combined With Gemcitabine and Oxaliplatin in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Secondary Central Nervous System Lymphoma (SCNSL)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-11

Completion Date

2029-06

Last Updated

2026-10-22

Healthy Volunteers

No

Interventions

DRUG

Glofitamab

(Cycle 1 step-up dosing): Glofitamab 2.5 mg intravenous infusion on Day 8 of Cycle 1 and 10 mg on Day 15 of Cycle 1. (Cycles 2-6): Glofitamab 30 mg intravenous infusion on Day 1 of Cycles 2 to 6. (Maintenance): Glofitamab 30 mg intravenous infusion on Day 1 of each 21-day maintenance cycle, for up to 6 cycles. Cycle 1 uses step-up dosing of 2.5 mg (Day 8) and 10 mg (Day 15) to reduce the risk of cytokine release syndrome; the dose is increased to 30 mg from Cycle 2 onwards. Each cycle is 21 days (3 weeks).

DRUG

Gemcitabine

Gemcitabine 1 g/m2 intravenous infusion on Day 2 of each 21-day cycle (Cycles 1-6).

DRUG

Oxaliplatin

Oxaliplatin 100 mg/m2 intravenous infusion on Day 2 of each 21-day cycle (Cycles 1-6).

RADIATION

ASCT or whole-brain radiotherapy (WBRT)

After 6 cycles of study treatment, participants achieving partial or complete response may receive investigator-assessed autologous stem cell transplantation (ASCT) or whole-brain radiotherapy (WBRT), followed by glofitamab maintenance.

DRUG

Obinutuzumab

Obinutuzumab 1000 mg intravenous infusion on Day 1 of Cycle 1.

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China