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

Recruiting now · Phase 2

Conditions studied: B Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT06213311

Run by

M.D. Anderson Cancer Center

People needed

40

Starts

2024-05-07

Expected to finish

2027-07-31

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Platelet count either ≥ 75,000/μL or >50K if documented lymphomatous involvement of bone marrow
• Absolute lymphocyte count ≥ 100/μL
• Creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 ml/min
• Serum alanine aminotransferase and aspartate aminotransferase ≤ 2.5 upper limit of normal (ULN)
• Total bilirubin ≤ 1.5 mg/dL, except in participants with Gilbert's syndrome
• Cardiac ejection fraction ≥ 45%, no evidence of pericardial effusion (except trace or physiological) as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings
• No clinically significant pleural effusion
• Baseline oxygen saturation > 92% on room air
• At least 2 weeks must have elapsed since any prior systemic therapy at the time the participants is planned for leukapheresis.
• Toxicities due to prior therapy must be recovered to Grade 1 or less (except for clinically non-significant toxicities such as alopecia).

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.
• Administration of a live, attenuated vaccine within 4 weeks before Gpt infusion or anticipation that such a live attenuated vaccine will be required during the study. (Note: Influenza vaccination should be given during influenza season only). Patients must not receive live, attenuated influenza vaccine (e.g., Flumist®) at any time during the study treatment period.
• Participants who have not recovered from AEs due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
• Participants who are receiving any other investigational agents.
• Women of childbearing potential who are pregnant or breastfeeding. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential.
• Participants who are not willing to practice birth control for the duration of study participation, and 4 months after completion of C6 of glofitamab administration.
• In the investigator's judgment, the participant is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.
• Participants with a known or suspected history of HLH
• Participants with known or suspected chronic active EBV or CMV infection
• Prior treatment with systemic immunotherapeutic agents, including but not limited to radio-immunoconjugates, antibody-drug conjugates, immune/cytokines and monoclonal antibodies (e.g., anti-CTLA4, anti-PD1 and anti-PDL1) within 4 weeks or five half-lives of the drug, whichever is shorter, before Gpt infusion.
• Prior solid organ transplantation

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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