Actively Recruiting
A Phase 2 Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma
Led by M.D. Anderson Cancer Center · Updated on 2026-01-14
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of axicabtagene ciloleucel (axi-cel) and glofitamab as a second-line treatment for patients with relapsed or refractory large B cell lymphoma (LBCL). This phase 2 study aims to assess the safety and effectiveness of this combination therapy in controlling the disease, including its impact on complete response rates, overall survival, and progression-free survival. The study also explores tumor characteristics, genetic markers, circulating tumor DNA, and immune responses during treatment. Participants will receive a combination of three drugs: axicabtagene ciloleucel (axi-cel), glofitamab, and obinutuzumab, all given by intravenous infusion. Glofitamab is administered using a step-up dosing schedule. The study involves hospitalization at the start of glofitamab treatment to monitor safety. Treatment is given as second-line therapy for those whose disease is refractory or relapsed within 12 months after first-line chemoimmunotherapy. During the study, participants will undergo various assessments including safety monitoring of adverse events for about one year. Researchers will evaluate treatment effects using imaging, tumor profiling, genetic testing, and blood tests for tumor DNA and immune markers. Participants must comply with study visits, hospitalizations, and contraceptive requirements. The study continues until disease control and safety outcomes are fully assessed.
CONDITIONS
Brief Title
A Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven CD19- and CD20-positive large B cell lymphoma, including transformation from indolent lymphomas
- Disease refractory to or relapsed within 12 months after first-line chemoimmunotherapy
- Progressive disease as best response to first-line therapy or stable disease after at least 4 cycles or partial response after at least 6 cycles with biopsy-proven residual disease
- First-line therapy included anti-CD20 monoclonal antibody and anthracycline chemotherapy
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Ability and willingness to comply with hospitalization upon first dose of glofitamab
- Adequate bone marrow, kidney, liver, lung, and heart function as specified
- At least 2 weeks since prior systemic therapy before leukapheresis
- Recovery from prior therapy toxicities to Grade 1 or less except alopecia
- No suspicion of central nervous system lymphoma involvement
- Undetectable hepatitis B viral load if chronic infection present and cured hepatitis C virus infection
- Treated secondary CNS lymphoma with no evidence of disease on follow-up imaging
- No active cardiac symptoms and adequate cardiac function
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective contraception during and after treatment as specified
- Ability to understand and sign informed consent
- Specific stable autoimmune diseases allowed under defined conditions
- History of stroke allowed if no recent events and no residual deficits
You will not qualify if you...
- Prior CAR T-cell therapy or glofitamab therapy
- History of severe hypersensitivity to aminoglycosides
- Uncontrolled infection requiring hospitalization or IV antibiotics within 4 weeks
- Uncontrolled HIV infection or active hepatitis B or C infection
- Presence of indwelling lines or drains except certain central venous catheters
- Malignant cells in cerebrospinal fluid, brain metastases, or active CNS lymphoma
- CNS disorders or autoimmune diseases involving CNS
- Cardiac lymphoma involvement or significant cardiovascular disease
- Need for urgent therapy due to tumor mass effects
- Primary immunodeficiency or autoimmune diseases listed
- Recent symptomatic deep vein thrombosis or pulmonary embolism
- Medical conditions interfering with safety or efficacy assessment
- Allergic reactions to study drugs or similar compounds
- Recent live attenuated vaccine administration
- Unrecovered adverse events from prior cancer therapy except alopecia
- Receiving other investigational agents
- Pregnant or breastfeeding women or those unwilling to use birth control
- Unlikely to complete study visits or comply with requirements
- Known or suspected HLH or chronic active EBV or CMV infection
- Prior systemic immunotherapy within 4 weeks
- Prior solid organ transplantation
- History of progressive multifocal leukoencephalopathy
- Current or past CNS disease such as stroke or epilepsy
- Recent SARS-CoV-2 infection within 30 days before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 year or until discontinuation
Participants receive axicabtagene ciloleucel (axi-cel) and glofitamab as combination therapy to treat relapsed or refractory large B cell lymphoma. Glofitamab is administered based on a step-up dosing regimen.
Multiple visits for treatment and monitoring during therapy
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jason Westin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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