A Phase I/IIA Study of PBCAR0191 Immunotherapy in People with Recurrent or Persistent Non-Hodgkin Lymphoma and B-Cell Acute Lymphoblastic Leukemia

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Full Title

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 Non-Hodgkin Lymphoma and r/r B-cell Acute Lymphoblastic Leukemia

Purpose

The purpose of this study is to assess the safety of the investigational drug PBCAR0191 in people with non-Hodgkin lymphoma (NHL) or B-cell acute lymphoblastic leukemia (ALL) that came back or continued to grow despite treatment. PBCAR0191 is made from white blood cells called T cells that are collected from blood samples donated by healthy people. The donor T cells are genetically changed in a laboratory to make the treatment.

Before receiving PBCAR0191, patients will receive chemotherapy to wipe out some of their immune cells, which helps PBCAR0191 fight cancer more effectively. PBCAR0191 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have NHL or B-cell ALL that continues to grow or came back despite at least two prior regimens of chemotherapy.
  • Patients’ cancers must contain the CD19 protein.
  • Patients should recover from the serious side effects of previous treatments before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Craig Sauter at 212-639-3460.

Protocol

20-135

Phase

I/II

Investigator

Co-Investigators