A Phase 1 Study of GDA-201 in People with B Cell Non-Hodgkin Lymphoma


Full Title

A Phase I/II Multicenter Study Evaluating the Safety and Efficacy of Allogeneic GDA-201 Natural Killer Cells in Patients with Relapsed/Refractory B Cell Non-Hodgkin Lymphoma


The purpose of this study is to find the highest dose of the investigational cellular therapy GDA-201 that can be given safely in people with B cell non-Hodgkin lymphoma that has come back or continued to grow despite prior treatment. In the second part of the study, researchers will determine the likelihood that patients treated with the highest tolerated dose of GDA-201 will achieve remission of non-Hodgkin lymphoma.

GDA-201 is made in a laboratory using natural killer cells (NK cells) that come from the blood of a healthy donor. NK cells are a type of immune cell that have proteins that can kill cancer cells. Participants will receive standard chemotherapy drugs with GDA-201, including rituximab, cyclophosphamide, fludarabine, and interleukin-2.

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have B cell non-Hodgkin lymphoma (such as follicular lymphoma or diffuse large B cell lymphoma) which has come back or continued to grow despite at least two prior regimens of treatment.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.


For more information and to ask about eligibility for this study, please contact the office of Dr. Brian Shaffer at 646-608-2091.




Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory



ClinicalTrials.gov ID