A Phase 1/2 Open-label, Multicenter Study of Lenzilumab and Axicabtagene Ciloleucel in Subjects with Relapsed or Refractory Large B-cell Lymphoma (ZUMA-19)
Sponsor: |
Kite, A Gilead Company |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAS9231 |
U.S. Govt. ID: |
NCT04314843 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
The purpose of this study is to find out if the experimental combination of lenzilumab (an antibody that blocks the cytokine GM-CSF) and axicabtagene ciloleucel (which is identical to the FDA-approved CAR-T cell product YESCARTA) helps in protecting patients from side effects of axicabtagene ciloleucel. While axicabtagene ciloleucel has been approved by the FDA for use with your disease, there is a chance of developing neurologic side effects when it is given alone. The study will test if the addition of lenzilumab does or does not improve the safety of axicabtagene ciloleucel.Additionally, the study will test if lenzilumab helps improve the efficacy of CAR-T cells. Lenzilumab is not approved for use in any disease indication, but it has been studied in other clinical trials involving 114 patients.
This study is closed
Investigator
Ran Reshef, MD
Are you at least 18 years of age? |
Yes |
No |
Have you been diagnosed with large B-cell lymphoma? |
Yes |
No |
Has your disease had no response to at least 2 lines of prior therapy such as radiation or chemotherapy? |
Yes |
No |