Purpose of this Study
We are doing this study to find out if an experimental CAR-T cell therapy called MB-CART2019.1 (the study drug) may help eliminate cancer cells in patients who have relapsed or refractory DLBCL. The study drug will be combined with fludarabine and cyclophosphamide, which are both standard drugs used to treat DLBCL.
Who Can Participate?
Eligibility
Adults diagnosed with DLBCL who:
- Have relapsed from previous treatment; OR
- Did not have an adequate response to standard treatments
For more information about who can join this study, please contact the study team at peggy.alton@duke.edu or 919-684-9220.
- Have relapsed from previous treatment; OR
- Did not have an adequate response to standard treatments
For more information about who can join this study, please contact the study team at peggy.alton@duke.edu or 919-684-9220.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:
- Have a physical exam
- Have a heart scan (ECG)
- Have blood draws and give urine samples
- Have bone marrow samples taken
- Have images taken (X-ray or CT scan)
- Have a Lumbar puncture/tumor biopsy
If you are eligible to continue after screening, you will be scheduled for a procedure called leukapheresis to collect some of your white blood cells. After your cells are collected, they will be sent to a laboratory to be genetically modified to become activated and kill the lymphoma cells.
Before you are treated with these modified CAR T-cells, you will receive fludarabine and cyclophosphamide as conditioning therapy for 3 days. You will check in to the hospital before the infusion of the CAR T-cells and stay for at least 24 hours afterward. You might stay in the hospital for a longer period of time to be monitored if you are one of the first 20 participants in the study.
After you check out of the hospital, you will:
- Visit our clinic every day until it has been 14 days since your CAR-T infusion
- Visit our clinic weekly once it has been 14 days since your CAR-T infusion
- Visit our clinic every 3 months once it has been 28 days since your CAR-T infusion
- Visit our clinic every 6 months once it has been 1 year since your CAR-T infusion
- Stop coming in for follow-up visits once it has been 2 years since your CAR-T infusion
- Have a physical exam
- Have a heart scan (ECG)
- Have blood draws and give urine samples
- Have bone marrow samples taken
- Have images taken (X-ray or CT scan)
- Have a Lumbar puncture/tumor biopsy
If you are eligible to continue after screening, you will be scheduled for a procedure called leukapheresis to collect some of your white blood cells. After your cells are collected, they will be sent to a laboratory to be genetically modified to become activated and kill the lymphoma cells.
Before you are treated with these modified CAR T-cells, you will receive fludarabine and cyclophosphamide as conditioning therapy for 3 days. You will check in to the hospital before the infusion of the CAR T-cells and stay for at least 24 hours afterward. You might stay in the hospital for a longer period of time to be monitored if you are one of the first 20 participants in the study.
After you check out of the hospital, you will:
- Visit our clinic every day until it has been 14 days since your CAR-T infusion
- Visit our clinic weekly once it has been 14 days since your CAR-T infusion
- Visit our clinic every 3 months once it has been 28 days since your CAR-T infusion
- Visit our clinic every 6 months once it has been 1 year since your CAR-T infusion
- Stop coming in for follow-up visits once it has been 2 years since your CAR-T infusion
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A multi-center single arm Phase II study to evaluate the safety and efficacy of genetically engineered autologous cells expressing anti-CD20 and anti-CD19 specific chimeric antigen receptor in subjects with relapsed and/or refractory diffuse large B cell lymphoma
Principal Investigator
Ahmed
Galal
Protocol Number
PRO00105486
NCT ID
NCT04792489
Phase
II
Enrollment Status
OPEN TO ACCRUAL