A Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma

NCT06213311 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2023-0673NCI-2024-00209
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To learn if the combination of axicabtagene ciloleucel (axi-cel) and glofitamab as first-line therapy in high-risk LBCL participants or as second-line therapy in LBCL participants can help to control the disease.

Conditions

B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events

  Through study completion; an average of 1 year

Study Arms (1)

Axicabtagene Ciloleucel (axi-cel) and Glofitamab

EXPERIMENTAL

Participants will receive glofitamab based on a step-up dosing regimen.

Drug: Glofitamab; Drug: Obinutuzumab; Drug: Axi-cel

Interventions

Glofitamab DRUG

Given by IV

Also known as: RO7082859, RG6026

Axicabtagene Ciloleucel (axi-cel) and Glofitamab

Obinutuzumab DRUG

Given by IV

Also known as: GA101, Gazyva, RO5072759

Axicabtagene Ciloleucel (axi-cel) and Glofitamab

Axi-cel DRUG

Given by IV

Also known as: Axicabtagene ciloleucel, KTE-C19, KTE-X19

Axicabtagene Ciloleucel (axi-cel) and Glofitamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven CD19- and CD20-positive LBCL, including transformation from indolent lymphomas.
• Have disease that is refractory to or relapsed \<=12 months after the completion of first-line chemoimmunotherapy
• Refractory disease defined as no complete response (CR) to first-line therapy; participants who are intolerant to first-line therapy are excluded
• Progressive disease (PD) as best response to first-line therapy
• Stable disease (SD) as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP)
• Partial response (PR) as best response after at least 6 cycles, and biopsy-proven residual disease or disease progression ≤ 12 months from completion of therapy
• Relapsed disease defined as CR to first-line therapy followed by biopsy- proven disease relapse ≤ 12 months of completing first-line therapy.
• Participants must have received first-line therapy including:
• Anti-CD20 monoclonal antibody
• An anthracycline containing chemotherapy regimen
• Age 18 or older
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
• Participants must be willing and able to comply with protocol-mandated hospitalization upon administration of the first dose of glofitamab.
• Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:
• Absolute neutrophil count ≥ 1000/μL

You may not qualify if:

• Prior CAR T-cell therapy or glofitamab therapy.
• History of severe, immediate hypersensitivity reaction attributed to aminoglycosides.
• Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring hospitalization and/or intravenous (IV) antimicrobials for management within 4 weeks of treatment initiation; simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the sponsor's medical monitor.
• History of uncontrolled human immunodeficiency virus (HIV) infection (HIV+ patients are not excluded from study if they have CD4 counts ≥ 200/µl, are on stable antiretroviral therapy for at least 1 month prior to study entry, and who have an undetectable viral load) or acute or chronic active hepatitis B or C infection; patients with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America guidelines.
• Presence of any in dwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter); dedicated central venous access catheters, such as a Port-A-Cath® or Hickman® catheter, are permitted.
• Participants with detectable cerebrospinal fluid malignant cells, brain metastases, or active CNS lymphoma.
• History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
• Participants with cardiac lymphoma involvement.
• History of significant or extensive cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 3 months, unstable arrhythmias, or unstable angina.
• Requirement for urgent therapy due to tumor mass effects (e.g., blood vessel compression, bowel obstruction, or transmural gastric involvement).
• Primary immunodeficiency.
• History of autoimmune disease, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
• History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment.
• Any medical condition likely to interfere with assessment of safety or efficacy of study treatment.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to axi-cel, glofitamab, obinutuzumab, or other agents used in the study.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genentech, Inc.: collaborator
• Kite, A Gilead Company: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

glofitamab; obinutuzumab; axicabtagene ciloleucel; brexucabtagene autoleucel

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jason Westin, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Westin, MD

CONTACT

(713) 792-3750; jwestin@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: May 7, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (1)