Recruiting
Phase 2

Glofitamab & Gemcitabine, Oxaliplatin

Sponsor:

Hoffmann-La Roche

Code:

NCT06806033

Conditions

B-Cell Non-Hodgkins Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Obinutuzumab

Glofitamab

Gemcitabine

Oxaliplatin

Study Details

Brief summary:

This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) in participants with relapsed or refractory aggressive B-cell Non-Hodgkin's lymphoma. The study utilizes an optimized steroid premedication regimen and monitoring schedule specifically designed to enable the administration of the treatment regimen in an outpatient setting.

Conditions

B-Cell Non-Hodgkins Lymphoma

Study ID

NCT06806033

Start date

Mar 5, 2025

Status verified date

Aug, 2026

Completion date

Mar 30, 2029

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically confirmed large B-cell lymphoma (de novo or transformed from FL) with one of the following diagnoses according to World Health Organization, fifth edition: DLBCL Not Otherwise Specified (NOS); High-Grade B-Cell Lymphoma (HGBL), NOS; DLBCL/HGBL with MYC and BCL2 rearrangements
  • R/R disease, defined as: relapsed = disease that has recurred following a response that lasted >/= 6 months after completion of the last line of therapy; refractory = disease that did not respond to or that progressed < 6 months after completion of the last line of therapy
  • At least one line of prior systemic therapy
  • Participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
  • At least one bi-dimensionally measurable (> 1.5 cm) nodal lesion, or one bi-dimensionally measurable (> 1 cm) extranodal lesion, as measured on CT scan
  • Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2
  • According to the investigator's judgment, participants should be able to receive the step-up dose regimen in an outpatient setting
  • Adequate hematologic and renal function

Exclusion Criteria:

  • Prior enrollment in Studies GO41943 (NCT04313608), GO41944 (STARGLO; NCT04408638), or Study GO44900 (NCT06624085)
  • Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation
  • Any history of Waldenstrom's macroglobulinemia
  • Primary mediastinal B-cell lymphoma
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
  • Contraindication to obinutuzumab, gemcitabine or oxaliplatin, or tocilizumab
  • Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
  • Prior treatment with gemcitabine or oxaliplatin
  • Peripheral neuropathy or paresthesia assessed to be Grade >/= 2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrollment
  • Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment
  • Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment
  • Primary or secondary CNS lymphoma at the time of recruitment
  • Prior CNS involvement that has been definitively treated and confirmed via magnetic resonance imaging (MRI) or cerebrospinal fluid analysis to be in complete remission is permissible
  • Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  • History of other primary malignancy, with exceptions defined by the protocol
  • Significant or extensive cardiovascular disease
  • Significant pulmonary disease (including moderate or severe obstructive pulmonary disease)
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 4 weeks prior to the first study treatment
  • Positive for: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); tuberculosis; hepatitis B virus (HBV); hepatitis C virus (HCV); chronic active Epstein-Barr viral infection
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) or progressive multifocal leukoencephalopathy
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better (with the exception of alopecia and anorexia)
  • Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
  • Prior solid organ transplantation or prior allogenic stem cell transplant
  • Active autoimmune disease requiring treatment
  • Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents), within 4 weeks prior to first dose of study treatment
  • Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the participant at increased risk of steroid-related iatrogenic adrenal insufficiency
  • Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
  • Clinically significant history of cirrhotic liver disease
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high-risk from treatment complications
  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 18 months after the final dose of study treatment

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: R/R Aggressive B-Cell Non-Hodgkin's Lymphoma

Participants with R/R aggressive B-cell Non-Hodgkin's Lymphoma will receive obinutuzumab pre-treatment, followed by glofitamab + gemcitabine + oxaliplatin, followed by glofitamab monotherapy.

Interventions

Obinutuzumab

Participants will receive intravenous (IV) obinutuzumab 7 days prior to the first dose of glofitamab.

Glofitamab

Participants will receive IV glofitamab, both in combination with gemcitabine and oxaliplatin and as monotherapy, for up to 12 cycles (cycle length = 21 days).

Gemcitabine

Participants will receive IV gemcitabine in combination with glofitamab and oxaliplatin for up to 8 cycles (cycles length = 21 days).

Oxaliplatin

Participants will receive IV oxaliplatin in combination with glofitamab and gemcitabine for up to 8 cycles (cycle length = 21 days).

Primary outcome measure

  • Incidence of cytokine release syndrome (CRS) [ Time Frame: Up to approximately 5 years ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: GO45434 https://forpatients.roche.com/ No email attachments.

888-662-6728global-roche-genentech-trials@gene.com

Locations

Alaska Oncology & Hematology, LLC

Recruiting

Anchorage, Alaska, United States, 99508

Community Cancer Institute (CCI)

Recruiting

Clovis, California, United States, 93611

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

Los Angeles Cancer Network

Recruiting

Glendale, California, United States, 91204

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

Valkyrie Clinical Trials

Recruiting

Panorama City, California, United States, 91402

Zuckerberg San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94110

The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente

Recruiting

Torrance, California, United States, 90502-2006

Rocky Mountain Cancer Centers, LLP

Recruiting

Aurora, Colorado, United States, 80012

North Florida/ South Georgia VA Medical Center

Recruiting

Gainesville, Florida, United States, 32608

Mount Sinai Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33140

Orlando Health Cancer Institute

Recruiting

Orlando, Florida, United States, 32806

St Luke?s Cancer Institute

Recruiting

Boise, Idaho, United States, 83712

Cancer Care Specialists of Central Illinois

Recruiting

Swansea, Illinois, United States, 62226

Mission Blood and Cancer - MercyOne Cancer Center

Recruiting

Waukee, Iowa, United States, 50263

University of Kentucky - Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Mary Bird Perkins Cancer Ctr

Recruiting

Baton Rouge, Louisiana, United States, 70809

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Corewell Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

New York Oncology Hematology, P.C.

Recruiting

Albany, New York, United States, 12206

Hematology Oncology Associates of Central New York

Recruiting

East Syracuse, New York, United States, 13057

Oncology Associates of Oregon, P.C

Recruiting

Eugene, Oregon, United States, 97401

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Providence St. Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Tennessee Oncology

Recruiting

Chattanooga, Tennessee, United States, 37403

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Baylor Scott & White Health

Recruiting

Temple, Texas, United States, 76502

Texas Oncology - Gulf Coast

Recruiting

The Woodlands, Texas, United States, 77380

Texas Oncology- Northeast Texas

Recruiting

Tyler, Texas, United States, 75702

Virginia Cancer Specialists, PC

Recruiting

Fairfax, Virginia, United States, 22031

Virginia Oncology Associates - Virginia Beach

Recruiting

Virginia Beach, Virginia, United States, 23456

Northwest Medical Specialties

Recruiting

Tacoma, Washington, United States, 98405

Arthur J.E. Child Comprehensive Cancer Center

Recruiting

Calgary, Alberta, Canada, T2N 5G2

CancerCare Manitoba (CCMB)

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Phase 2
  • Outpatient study
  • Open-label
  • Glofitamab
  • Gemcitabine
  • Oxaliplatin
  • Obinutuzumab
  • GemOx
  • Glofit-GemOx
  • Bispecific antibody
  • Aggressive B-cell Non-Hodgkin's lymphoma
  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • DLBCL NOS (Not Otherwise Specified)
  • High-Grade B-Cell Lymphoma (HGBL)
  • HGBL NOS
  • Transformed follicular lymphoma
  • DLBCL/HGBL with MYC and BCL2 rearrangements
  • Double-hit lymphoma
  • Relapsed or Refractory (R/R)
  • Non-Hodgkin Lymphoma (NHL)
  • Cytokine Release Syndrome (CRS)
  • CRS optimization
  • Step-up dosing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-14.