PCNSL (Primary CNS Lymphoma)Phase 2NCT07888621
Glofitamab Plus Gemcitabine and Oxaliplatin (GemOx) in Relapsed or Refractory Primary and Secondary Central Nervous System Lymphoma
A Phase 2 study testing Glofitamab, Gemcitabine and Oxaliplatin in people with PCNSL (Primary CNS Lymphoma) and Central Nervous System Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PCNSL (Primary CNS Lymphoma), Central Nervous System Lymphoma, Secondary Central Nervous System Lymphoma (SCNSL)
- What is being tested?
- Glofitamab, Gemcitabine and Oxaliplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to Jun 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Histopathologically confirmed relapsed/refractory primary central nervous system lymphoma (PCNSL), or secondary central nervous system lymphoma (SCNSL) with isolated central nervous system relapse
- 2. Written informed consent obtained, and the participant is able to comply with the protocol-specified visits and procedures
- 3. Whole-body PET/CT and brain MRI (plain plus contrast) performed within 28 days before enrolment must show at least one measurable lesion in two perpendicular dimensions (according to the Lugano 2014 criteria)
- 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 4
- 5. Adequate organ and bone marrow function, defined as: complete blood count - absolute neutrophil count (ANC) >= 1.0 x 10^9/L, platelet count (PLT) >= 50 x 10^9/L, and haemoglobin (HGB) >= 8.0 g/dL; no granulocyte growth factor, platelet transfusion or red blood cell transfusion within 7 days before testing
- 6. Hepatic function: serum total bilirubin (TBIL) <= 1.5 x upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 x ULN
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- 7. Renal function: serum creatinine (Cr) <= 2 x ULN, or creatinine clearance (CCR) >= 60 mL/min
- 8. Cardiac function: New York Heart Association (NYHA) class below III; left ventricular ejection fraction >= 50% on echocardiography
- 9. Coagulation function: international normalised ratio (INR) <= 1.5 x ULN, activated partial thromboplastin time (APTT) <= ULN + 10 s, and prothrombin time (PT) <= ULN + 3 s
- 10. Life expectancy of more than 3 months
- 11. Age 18 years or older
- 12. Women of childbearing potential and male participants with a female partner of childbearing potential must use effective contraception throughout the treatment period and for 90 days after the last dose of study treatment
Who cannot join
- 1. Involvement of any site outside the central nervous system
- 2. A second primary malignancy (except non-melanoma in-situ skin cancer, superficial bladder cancer, in-situ cervical cancer, gastrointestinal intramucosal carcinoma, or breast cancer that has been cured with no recurrence within 5 years)
- 3. Previous allogeneic organ transplantation or allogeneic haematopoietic stem cell transplantation
- 4. Anticipated need for any other systemic anticancer therapy during the study period
- 5. Anti-tumour vaccine or other immunostimulatory anticancer therapy within 3 months before the first dose
- 6. Severe acute or chronic infection requiring systemic treatment
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- 7. Human immunodeficiency virus antibody (HIV-Ab) positivity, active hepatitis, or any other uncontrolled infectious disease
- 8. Current or prior idiopathic pulmonary fibrosis or idiopathic pneumonia
- 9. Known active pulmonary tuberculosis
- 10. Grade >= 3 immune-related adverse events during previous immunotherapy
- 11. Documented history of neurological or psychiatric disorders
- 12. Receipt of any live vaccine for infectious diseases (e.g., influenza vaccine, varicella vaccine) within 4 weeks before the first dose, or planned use during the study period
- 13. Documented history of alcohol or drug abuse
- 14. Pregnant or breastfeeding women
- 15. Receipt of any other investigational active drug within 1 month before the first dose
- 16. Any other condition that, in the investigator's opinion, may affect the efficacy or safety assessment of this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
Lei Fan, Doctor, 13813976136, fanlei3014@126.com
About this study
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)
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.
- Conditions
- PCNSL (Primary CNS Lymphoma), Central Nervous System Lymphoma, Secondary Central Nervous System Lymphoma (SCNSL)
- Being tested
- Glofitamab, Gemcitabine, Oxaliplatin, ASCT or whole-brain radiotherapy (WBRT), Obinutuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlofitamabDrug
(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).
GemcitabineDrug
Gemcitabine 1 g/m2 intravenous infusion on Day 2 of each 21-day cycle (Cycles 1-6).
OxaliplatinDrug
Oxaliplatin 100 mg/m2 intravenous infusion on Day 2 of each 21-day cycle (Cycles 1-6).
ASCT or whole-brain radiotherapy (WBRT)Radiation
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.
ObinutuzumabDrug
Obinutuzumab 1000 mg intravenous infusion on Day 1 of Cycle 1.
| Study group | Role | What they receive |
|---|---|---|
| Glofitamab plus gemcitabine and oxaliplatin (GemOx) | Experimental | Not described Receives: Drug: Glofitamab; Drug: Gemcitabine; Drug: Oxaliplatin; Radiation: ASCT or whole-brain radiotherapy (WBRT); Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: 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).
Secondary outcomes (4)
Complete Response Rate (CRR)
Measured: 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
Measured: Efficacy assessed every 3 months during the first year; follow-up for 1 year from first dose.
1-Year Overall Survival (OS) Rate
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCNSL (Primary CNS Lymphoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Fan, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888621
- Sponsor's protocol ID
- 2026-SR-679
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No