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CAR T-cell Therapy
Axi-cel + Glofitamab for B-Cell Lymphoma
Phase 2
Recruiting
Led By Jason Westin, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 or older
Histologically proven CD19- and CD20-positive LBCL, including transformation from indolent lymphomas
Must not have
Participants with cardiac lymphoma involvement
Requirement for urgent therapy due to tumor mass effects
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying whether a combination of two drugs, axicabtagene ciloleucel (axi-cel) and glofitamab, can be effective in treating a type of
Who is the study for?
This trial is for patients with Large B Cell Lymphoma who have already tried one treatment without success. Participants should be high-risk and looking to try a combination of two drugs, Axi-cel and Glofitamab, as either their first or second line of therapy.
What is being tested?
The study tests if using Axicabtagene Ciloleucel (Axi-cel) together with Glofitamab can control the disease in those with relapsed or refractory Large B Cell Lymphoma. It's given after the first treatment fails or as an initial high-risk therapy.
What are the potential side effects?
Possible side effects from Axi-cel and Glofitamab may include fever, fatigue, immune system reactions, neurological events like confusion or seizures, and infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My lymphoma is confirmed to be CD19 and CD20 positive.
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I have received initial treatment with anti-CD20 and anthracycline for my condition.
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My disease did not respond or came back within a year after my first chemoimmunotherapy.
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My lymphoma has not spread to my brain or spinal cord.
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I can take care of myself but might not be able to do heavy physical work.
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I have chronic hepatitis B but it's under control with medication.
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I had hepatitis C but have been treated and cured.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My lymphoma affects my heart.
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I need urgent treatment because my tumor is causing symptoms.
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I have a history of serious heart disease.
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I have a history of or currently have a brain or nervous system disorder.
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I have had a serious blood clot in my leg or lung in the last 6 months.
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I have cancer cells in my brain or spinal fluid.
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I might have an infection that isn't responding to treatment.
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I do not have uncontrolled HIV or active hepatitis B or C.
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I am not pregnant or breastfeeding.
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I have previously received CAR T-cell or glofitamab therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and adverse events (AEs)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Axicabtagene Ciloleucel (axi-cel) and GlofitamabExperimental Treatment3 Interventions
Participants will receive glofitamab based on a step-up dosing regimen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glofitamab
2021
Completed Phase 1
~60
Obinutuzumab
2014
Completed Phase 3
~3470
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
569,960 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,505 Total Patients Enrolled
Kite, A Gilead CompanyIndustry Sponsor
44 Previous Clinical Trials
3,919 Total Patients Enrolled
Jason Westin, MDPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
158 Total Patients Enrolled