A Phase 2 interventional study of Glofitamab and Gemcitabine in PCNSL (Primary CNS Lymphoma), Central Nervous System Lymphoma and Secondary Central Nervous System Lymphoma (SCNSL), sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 2, Interventional, and Treatment
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.
The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 563 studies on the registry; 311 are open to participants now.
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Drug: Glofitamab · Drug: Gemcitabine · Drug: Oxaliplatin · Radiation: ASCT or whole-brain radiotherapy (WBRT) · Drug: Obinutuzumab
(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).
Gemcitabine 1 g/m2 intravenous infusion on Day 2 of each 21-day cycle (Cycles 1-6).
Oxaliplatin 100 mg/m2 intravenous infusion on Day 2 of each 21-day cycle (Cycles 1-6).
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.
Obinutuzumab 1000 mg intravenous infusion on Day 1 of Cycle 1.
Objective Response Rate (ORR)
Time frame: Assessed after Cycle 3 (Week 9) and after Cycle 6 (Week 18); each cycle is 21 days. Non-responders discontinue; responders are assessed through maintenance, up to approximately Week 36 (longer if ASCT or WBRT is interposed).
Complete Response Rate (CRR)
Time frame: Assessed after Cycle 3 (Week 9) and after Cycle 6 (Week 18); each cycle is 21 days. Non-responders discontinue; responders are assessed through maintenance, up to approximately Week 36 (longer if ASCT or WBRT is interposed).
1-Year Progression-Free Survival (PFS) Rate
Time frame: Efficacy assessed every 3 months during the first year; follow-up for 1 year from first dose.
1-Year Overall Survival (OS) Rate
Time frame: Follow-up every 3 months during the first year and every 6 months during the second year; follow-up for 1 year from first dose.
Incidence of Adverse Events and Serious Adverse Events
Time frame: From first dose until at least 30 days after the last dose (AEs followed until resolution or stabilisation); weekly safety follow-up during treatment and every 3 months during long-term follow-up up to 2 years.
Plan to share: No
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Start is estimated for Nov 2026; primary completion for Dec 2028, 25 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Glofitamab · Gemcitabine · Oxaliplatin
The First Affiliated Hospital with Nanjing Medical University →