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Starting soon Phase 2

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

NCT07888621 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2026-11
Last updated
2026-10-22

Condition(s) studied

PCNSL (Primary CNS Lymphoma)Central Nervous System LymphomaSecondary Central Nervous System Lymphoma (SCNSL)

Investigational drug(s) / intervention(s)

Glofitamab →Gemcitabine →Oxaliplatin →ASCT or whole-brain radiotherapy (WBRT)Obinutuzumab →

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).

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

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

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.

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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

Primary outcome measure(s)

  • Objective Response Rate (ORR) — 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).

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital with Nanjing Medical University Nanjing Jiangsu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07888621 on ClinicalTrials.gov ↗ ← All trials in China