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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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
What is being tested?
Glofitamab, Gemcitabine and Oxaliplatin
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
Are there results?
Not yet: the study is under way

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.

Lei Fan contact

13813976136

fanlei3014@126.com

China1 site

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu

    Lei Fan, Doctor, 13813976136, fanlei3014@126.com

Other trials in China

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.

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 groups in NCT07888621
Study groupRoleWhat they receive
Glofitamab plus gemcitabine and oxaliplatin (GemOx)ExperimentalNot 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.

  1. 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)

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  1. First posted22 Oct 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lei Fan (13813976136, fanlei3014@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07888621.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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