Purpose of this Study
We are doing this study to find out if an experimental drug called PBCAR0191-01 (the study drug) is a safe and effective option for people with B-cell Acute Lymphoblastic leukemia (B-ALL) and non-Hodgkin lymphoma (NHL). The study drug is made from donated human T-cells and is a type of immunotherapy called CAR T (chimeric antigen receptor). We want to know if the study drug will be helpful for people who do not have lasting results from standard treatments.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with B-ALL or NHL.
- 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 quinna.marshburn@@duke.edu.
- Are diagnosed with B-ALL or NHL.
- 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 quinna.marshburn@@duke.edu.
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
- Have bone marrow samples taken
- Have a tumor biopsy (NHL only)
- Have a lumbar puncture (B-ALL only)
- Have imaging (CT scan or PET/CT) (NHL only)
If you are eligible, you will be treated with LD chemotherapy (fludarabine and cyclophosphamide) for three days to prepare your body for the study drug infusion. After you get a single dose of the study drug, we will schedule you for return appointments to have exams and to have your health monitored.
- Have a physical exam
- Have a heart scan (ECG)
- Have blood draws
- Have bone marrow samples taken
- Have a tumor biopsy (NHL only)
- Have a lumbar puncture (B-ALL only)
- Have imaging (CT scan or PET/CT) (NHL only)
If you are eligible, you will be treated with LD chemotherapy (fludarabine and cyclophosphamide) for three days to prepare your body for the study drug infusion. After you get a single dose of the study drug, we will schedule you for return appointments to have exams and to have your health monitored.
Study Details
Full Title
Precision BioSciences - A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191 in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)
Principal Investigator
Ahmed
Galal
Protocol Number
PRO00111284
NCT ID
NCT03666000
Phase
I/II
Enrollment Status
OPEN TO ACCRUAL