A Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Last updated: March 27, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

2

Condition

Hematologic Cancer

Lymphoma, B-cell

Lymphoma

Treatment

Obinutuzumab

Gemcitabine

Glofitamab

Clinical Study ID

NCT06806033
GO45434
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed large B-cell lymphoma (de novo or transformed from FL) withone of the following diagnoses according to World Health Organization, fifthedition: 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 responsethat 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 ofthe 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 candidatefor high-dose chemotherapy followed by autologous stem cell transplant (ASCT)

  • At least one bi-dimensionally measurable (> 1.5 cm) nodal lesion, or onebi-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 thestep-up dose regimen in an outpatient setting

  • Adequate hematologic and renal function

Exclusion

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 stemcell transplantation

  • Any history of Waldenstrom's macroglobulinemia

  • Primary mediastinal B-cell lymphoma

  • History of severe allergic or anaphylactic reactions to humanized or murinemonoclonal antibodies (or recombinant antibody-related fusion proteins) or knownsensitivity or allergy to murine products

  • Contraindication to obinutuzumab, gemcitabine or oxaliplatin, or tocilizumab

  • Prior treatment with glofitamab or other bispecific antibodies targeting both CD20and CD3

  • Prior treatment with gemcitabine or oxaliplatin

  • Peripheral neuropathy or paresthesia assessed to be Grade >/= 2 according to theNational 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 weeksprior to first study treatment

  • Treatment with monoclonal antibodies for the purposes of treating cancer within 4weeks 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 magneticresonance imaging (MRI) or cerebrospinal fluid analysis to be in complete remissionis permissible

  • Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, orneurodegenerative 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 pulmonarydisease)

  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episodeof infection (as evaluated by the investigator) within 4 weeks prior to the firststudy treatment

  • Positive for: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);tuberculosis; hepatitis B virus (HBV); hepatitis C virus (HCV); chronic activeEpstein-Barr viral infection

  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) orprogressive multifocal leukoencephalopathy

  • Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 orbetter (with the exception of alopecia and anorexia)

  • Administration of a live, attenuated vaccine within 4 weeks before first studytreatment administration or anticipation that such a live, attenuated vaccine willbe 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 notlimited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumornecrosis factor agents), within 4 weeks prior to first dose of study treatment

  • Ongoing systemic corticosteroid use which, in the opinion of the investigator, putsthe participant at increased risk of steroid-related iatrogenic adrenalinsufficiency

  • Recent major surgery (within 4 weeks before the first study treatment) other thanfor diagnosis

  • Clinically significant history of cirrhotic liver disease

  • Any other diseases, metabolic dysfunction, physical examination finding, or clinicallaboratory finding giving reasonable suspicion of a disease or condition thatcontraindicates the use of an investigational drug or that may affect theinterpretation of the results or renders the participant at high-risk from treatmentcomplications

  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study orwithin 18 months after the final dose of study treatment

Study Design

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Obinutuzumab
Phase: 2
Study Start date:
March 05, 2025
Estimated Completion Date:
March 30, 2029

Connect with a study center

  • Epworth Hospital

    East Melbourne, Victoria 3002
    Australia

    Active - Recruiting

  • Epworth Hospital

    East Melbourne 6952201, Victoria 2145234 3002
    Australia

    Site Not Available

  • Arthur J.E. Child Comprehensive Cancer Center

    Calgary, Alberta T2N 5G2
    Canada

    Active - Recruiting

  • Arthur J.E. Child Comprehensive Cancer Center

    Calgary 5913490, Alberta 5883102 T2N 5G2
    Canada

    Site Not Available

  • CancerCare Manitoba

    Winnipeg, Manitoba R3E 0V9
    Canada

    Active - Recruiting

  • CancerCare Manitoba (CCMB)

    Winnipeg, Manitoba R3E 0V9
    Canada

    Active - Recruiting

  • CancerCare Manitoba (CCMB)

    Winnipeg 6183235, Manitoba 6065171 R3E 0V9
    Canada

    Site Not Available

  • CHU de Grenoble

    La Tronche, 38700
    France

    Active - Recruiting

  • CHU de Grenoble

    La Tronche 3006131, 38700
    France

    Site Not Available

  • Chu de Montpellier-St Eloi

    Montpellier, 34295
    France

    Active - Recruiting

  • Chu de Montpellier-St Eloi

    Montpellier 2992166, 34295
    France

    Site Not Available

  • CHU de Bordeaux

    Pessac, 33600
    France

    Active - Recruiting

  • CHU de Bordeaux

    Pessac 2987805, 33600
    France

    Site Not Available

  • CHU DE RENNES - CHU Pontchaillou

    Rennes, 35033
    France

    Active - Recruiting

  • CHU DE RENNES - CHU Pontchaillou

    Rennes 2983990, 35033
    France

    Site Not Available

  • Chu De Tours

    Tours, 37000
    France

    Active - Recruiting

  • Chu De Tours

    Tours 2972191, 37000
    France

    Site Not Available

  • CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie

    Berlin, 12200
    Germany

    Active - Recruiting

  • Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)

    Berlin, 13353
    Germany

    Active - Recruiting

  • CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie

    Berlin 2950159, 12200
    Germany

    Active - Recruiting

  • Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)

    Berlin 2950159, 13353
    Germany

    Site Not Available

  • Universitätsklinikum Köln

    Cologne, 50937
    Germany

    Active - Recruiting

  • Universitätsklinikum Köln

    Cologne 2886242, 50937
    Germany

    Site Not Available

  • Otto von Guericke Uni Magdeburg Uniklinik

    Magdeburg, 39120
    Germany

    Active - Recruiting

  • Otto von Guericke Uni Magdeburg Uniklinik

    Magdeburg 2874545, 39120
    Germany

    Site Not Available

  • Istituto Nazionale Tumori Irccs Fondazione g. Pascale

    Naples, Campania 80131
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori Irccs Fondazione g. Pascale

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Istituto Nazionale Tumori Irccs Fondazione g. Pascale

    Napoli 9031661, Campania 3181042 80131
    Italy

    Site Not Available

  • IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"

    Meldola, Emilia-Romagna 47014
    Italy

    Active - Recruiting

  • IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"

    Meldola 3173635, Emilia-Romagna 3177401 47014
    Italy

    Site Not Available

  • Irccs Istituto Europeo Di Oncologia (IEO)

    Milano, Lombardia 20141
    Italy

    Site Not Available

  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili

    Brescia, Lombardy 25123
    Italy

    Active - Recruiting

  • Irccs Istituto Europeo Di Oncologia (IEO)

    Milan, Lombardy 20141
    Italy

    Active - Recruiting

  • Istituto Clinico Humanitas

    Rozzano, Lombardy 20089
    Italy

    Active - Recruiting

  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili

    Brescia 3181554, Lombardy 3174618 25123
    Italy

    Site Not Available

  • Irccs Istituto Europeo Di Oncologia (IEO)

    Milan 3173435, Lombardy 3174618 20141
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano 3168837, Lombardy 3174618 20089
    Italy

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707
    South Korea

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si 1897000, 463-707
    South Korea

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    South Korea

    Active - Recruiting

  • Asan Medical Center

    Seoul 1835848, 05505
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Site Not Available

  • Alaska Oncology & Hematology, LLC

    Anchorage, Alaska 99508
    United States

    Active - Recruiting

  • Alaska Oncology & Hematology, LLC

    Anchorage 5879400, Alaska 5879092 99508
    United States

    Site Not Available

  • Community Cancer Institute (CCI)

    Clovis, California 93611
    United States

    Active - Recruiting

  • Providence Medical Foundation

    Fullerton, California 92835
    United States

    Active - Recruiting

  • Los Angeles Cancer Network

    Glendale, California 91204
    United States

    Active - Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California 90067
    United States

    Active - Recruiting

  • Zuckerberg San Francisco General Hospital

    San Francisco, California 94110
    United States

    Active - Recruiting

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

    Torrance, California 90502-2006
    United States

    Active - Recruiting

  • Community Cancer Institute (CCI)

    Clovis 5338122, California 5332921 93611
    United States

    Site Not Available

  • Providence Medical Foundation

    Fullerton 5351247, California 5332921 92835
    United States

    Site Not Available

  • Los Angeles Cancer Network

    Glendale 5352423, California 5332921 91204
    United States

    Site Not Available

  • Valkyrie Clinical Trials

    Los Angeles 5368361, California 5332921 90067
    United States

    Site Not Available

  • Zuckerberg San Francisco General Hospital

    San Francisco 5391959, California 5332921 94110
    United States

    Site Not Available

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

    Torrance 5403022, California 5332921 90502-2006
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers, LLP

    Aurora, Colorado 80012
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Centers, LLP

    Aurora 5412347, Colorado 5417618 80012
    United States

    Site Not Available

  • North Florida/ South Georgia VA Medical Center

    Gainesville, Florida 32608
    United States

    Active - Recruiting

  • Mount Sinai Comprehensive Cancer Center

    Miami, Florida 33140
    United States

    Active - Recruiting

  • Orlando Health Cancer Institute

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • North Florida/ South Georgia VA Medical Center

    Gainesville 4156404, Florida 4155751 32608
    United States

    Site Not Available

  • Mount Sinai Comprehensive Cancer Center

    Miami 4164138, Florida 4155751 33140
    United States

    Site Not Available

  • Orlando Health Cancer Institute

    Orlando 4167147, Florida 4155751 32806
    United States

    Site Not Available

  • St Luke?s Cancer Institute

    Boise, Idaho 83712
    United States

    Active - Recruiting

  • St Luke?s Cancer Institute

    Boise 5586437, Idaho 5596512 83712
    United States

    Site Not Available

  • Cancer Care Specialists of Central Illinois

    Swansea, Illinois 62226
    United States

    Active - Recruiting

  • Cancer Care Specialists of Central Illinois

    Swansea 4251003, Illinois 4896861 62226
    United States

    Site Not Available

  • Mission Blood and Cancer - MercyOne Cancer Center

    Waukee, Iowa 50263
    United States

    Active - Recruiting

  • Mission Blood and Cancer - MercyOne Cancer Center

    Waukee 4880981, Iowa 4862182 50263
    United States

    Site Not Available

  • University of Kentucky - Markey Cancer Center

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • University of Kentucky - Markey Cancer Center

    Lexington 4297983, Kentucky 6254925 40536
    United States

    Site Not Available

  • Mary Bird Perkins Cancer Ctr

    Baton Rouge, Louisiana 70809
    United States

    Active - Recruiting

  • Mary Bird Perkins Cancer Ctr

    Baton Rouge 4315588, Louisiana 4331987 70809
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Boston Medical Center

    Boston 4930956, Massachusetts 6254926 02118
    United States

    Site Not Available

  • Nebraska Cancer Specialists

    Omaha, Nebraska 68130
    United States

    Active - Recruiting

  • Nebraska Cancer Specialists

    Omaha 5074472, Nebraska 5073708 68130
    United States

    Site Not Available

  • New York Oncology Hematology, P.C.

    Albany, New York 12206
    United States

    Active - Recruiting

  • Hematology Oncology Associates of Central New York

    East Syracuse, New York 13057
    United States

    Active - Recruiting

  • New York Oncology Hematology, P.C.

    Albany 5106834, New York 5128638 12206
    United States

    Site Not Available

  • Hematology Oncology Associates of Central New York

    East Syracuse 5116079, New York 5128638 13057
    United States

    Site Not Available

  • Oncology Associates of Oregon, P.C

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Providence St. Vincent Medical Center

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Oncology Associates of Oregon, P.C

    Eugene 5725846, Oregon 5744337 97401
    United States

    Site Not Available

  • Providence Portland Medical Center

    Portland 5746545, Oregon 5744337 97213
    United States

    Active - Recruiting

  • Providence St. Vincent Medical Center

    Portland 5746545, Oregon 5744337 97225
    United States

    Site Not Available

  • Tennessee Oncology

    Chattanooga, Tennessee 37403
    United States

    Active - Recruiting

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Tennessee Oncology

    Chattanooga 4612862, Tennessee 4662168 37403
    United States

    Site Not Available

  • Tennessee Oncology

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • Baylor Scott & White Health

    Temple, Texas 76502
    United States

    Active - Recruiting

  • Texas Oncology - Gulf Coast

    The Woodlands, Texas 77380
    United States

    Active - Recruiting

  • Texas Oncology- Northeast Texas

    Tyler, Texas 75702
    United States

    Active - Recruiting

  • Baylor Scott & White Health

    Temple 4735966, Texas 4736286 76502
    United States

    Site Not Available

  • Texas Oncology - Gulf Coast

    The Woodlands 4736476, Texas 4736286 77380
    United States

    Site Not Available

  • Texas Oncology- Northeast Texas

    Tyler 4738214, Texas 4736286 75702
    United States

    Site Not Available

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Virginia Cancer Specialists, PC

    Gainesville, Virginia 20155
    United States

    Site Not Available

  • Virginia Oncology Associates - Virginia Beach

    Virginia Beach, Virginia 23456
    United States

    Active - Recruiting

  • Virginia Cancer Specialists, PC

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

  • Virginia Cancer Specialists, PC

    Gainesville 4760363, Virginia 6254928 20155
    United States

    Site Not Available

  • Virginia Oncology Associates - Virginia Beach

    Virginia Beach 4791259, Virginia 6254928 23456
    United States

    Site Not Available

  • Northwest Medical Specialties

    Tacoma, Washington 98405
    United States

    Active - Recruiting

  • Northwest Medical Specialties

    Tacoma 5812944, Washington 5815135 98405
    United States

    Site Not Available

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