Actively Recruiting
A 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
142 weeks
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
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
Official 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 confirmed CD19- and CD20-positive large B cell lymphoma (LBCL), including transformation from indolent lymphomas
- Disease refractory to or relapsed within 12 months after first-line chemoimmunotherapy
- Refractory disease defined as no complete response to first-line therapy
- Progressive disease as best response to first-line therapy
- Stable disease after at least 4 cycles of first-line therapy
- Partial response after at least 6 cycles with biopsy-proven residual disease or progression within 12 months
- Received first-line therapy including anti-CD20 monoclonal antibody and anthracycline chemotherapy
- Age 18 years or older
- ECOG performance status 2 or less
- Willing and able to comply with hospitalization upon first dose of glofitamab
- Adequate bone marrow, kidney, liver, lung, and heart function
- At least 2 weeks since prior systemic therapy before leukapheresis
- Toxicities from prior therapy recovered to Grade 1 or less (except alopecia)
- No suspicion of central nervous system lymphoma involvement
- For chronic hepatitis B, viral load undetectable on suppressive therapy if needed
- Hepatitis C infection treated and cured or undetectable viral load if on treatment
- Treated secondary CNS lymphoma with no evidence of disease on follow-up imaging
- Malignancy less than 2 years old not interfering with study
- No active cardiac symptoms and adequate cardiac function
- Negative pregnancy test for females of childbearing potential
- Agreement to effective contraception during and after study as specified
- Ability to understand and sign informed consent
- Certain stable autoimmune diseases allowed under specified conditions
- History of stroke allowed if no events in past 2 years and no neurologic deficits
You will not qualify if you...
- Prior CAR T-cell or glofitamab therapy
- History of severe allergy to aminoglycosides
- Uncontrolled infections requiring hospitalization or IV antimicrobials within 4 weeks
- Uncontrolled HIV infection or active hepatitis B or C infection
- Presence of indwelling lines or drains (except certain central venous catheters)
- Detectable malignant cells in cerebrospinal fluid, brain metastases, or active CNS lymphoma
- History or presence of CNS disorders such as seizure, stroke, dementia, or autoimmune CNS diseases
- Cardiac lymphoma involvement
- Significant cardiovascular disease including recent myocardial infarction or unstable angina
- Need for urgent therapy due to tumor mass effects
- Primary immunodeficiency
- History of autoimmune diseases excluding specified stable conditions
- Recent deep vein thrombosis or pulmonary embolism within 6 months
- Medical conditions interfering with safety or efficacy assessments
- History of allergic reactions to study agents or similar compounds
- Live attenuated vaccine administration within 4 weeks before treatment
- Unrecovered toxicities from prior anti-cancer therapy above Grade 1 (except alopecia)
- Receiving other investigational agents
- Pregnant or breastfeeding women
- Unwillingness to use birth control as required
- Unlikely to comply with study visits or procedures
- Known or suspected hemophagocytic lymphohistiocytosis (HLH)
- Known or suspected chronic active EBV or CMV infection
- Recent immunotherapeutic agent treatments within 4 weeks before study
- Prior solid organ transplantation
- History of progressive multifocal leukoencephalopathy (PML)
- Current or past CNS diseases like stroke or epilepsy
- SARS-CoV-2 infection within 30 days prior to treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jason Westin, MD
CONTACT
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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