Precision Bio_PBCAR0191-01 (Non-Hodgkin Lymphoma & B-cell Acute Lymphoblastic Leukemia) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Non-Hodgkin Lymphoma (NHL) and B-cell Acute Lymphoblastic Leukemia (B-ALL)

Who Can Participate in the Study?

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.

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.

Study Details

Full Title
A Phase 1/1b, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191 (azercabtagene zapreleucel or “azer-cel”), 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
IRB: PRO00111284
NCT: NCT03666000
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment