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Official Title
A Phase Ib Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Phase
Phase 1
Sponsor
Hoffmann-La Roche
Enrollment
50
Timeline
Apr 2025 → Mar 2030
About This Study
The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in participants in the United States, including under-represented racial and ethnic populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
Eligibility Criteria
Inclusion Criteria
- 1Histologically confirmed DLBCL, not otherwise specified (NOS)
- 2Relapsed (disease that has recurred following a response that lasted ≥ 6 months after completion of the last line of therapy) or refractory ( disease that did not respond to or that progressed \< 6 months after completion of the last line of therapy) disease
- 3At least one prior line of systemic therapy
- 4Participants 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)
- 5At least one bi-dimensionally measurable (\> 1.5 cm) nodal lesion, or one bi-dimensionally measurable (\> 1 cm) extranodal lesion, as measured on CT scan
- 6Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Exclusion Criteria
- 1Prior enrollment in Study GO41944 (STARGLO; NCT04408638)
- 2Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation
- 3History of transformation of indolent disease to DLBCL
- 4High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS, as defined by 2016 WHO guidelines
- 5Primary mediastinal B-cell lymphoma
- 6History 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
- 7Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
- 8Prior treatment with gemcitabine or oxaliplatin
- 9Peripheral neuropathy or paresthesia assessed to be Grade \>/= 2 according to NCI CTCAE v5.0 at enrollment
- 10Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment
- 11Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment
- 12Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
- 13Prior CNS involvement that has been definitively treated and confirmed via MRI or cerebrospinal fluid analysis to be in complete remission is permissible
- 14Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- 15History of other primary malignancy, with exceptions defined by the protocol
- 16Significant or extensive cardiovascular disease, or significant pulmonary disease
- 17Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (exclusing fungal infections of nail beds) at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment
- 18Documented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months of first study treatment, or positive SARS-CoV-2 test within 7 days prior to enrollment
- 19Suspected or latent tuberculosis
- 20Positive test results for hepatitis B (HBV) or hepatitis C (HCV)
- 21Known or suspected chronic active Epstein-Barr viral infection
- 22Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- 23Known history of progressive multifocal leukoencephalopathy
- 24Prior solid organ transplantation
- 25Prior allogenic stem cell transplant
- 26Active autoimmune disease requiring treatment
- 27Prior treatment with systemic immunosuppressive medications within 4 weeks prior to first dose of study treatment
- 28Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the patient at increased risk of steroid-related iatrogenic adrenal insufficiency
- 29Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
- 30Clinically significant history of cirrhotic liver disease
Locations
14 sites participating in this study
Winship Cancer Institute of Emory University
Atlanta, Georgia 30329
UC San Diego Moores Cancer Center
La Jolla, California 92093
Saddleback Memorial Medical Center
Laguna Hills, California 92653
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →