A Phase 1 Study of CAR T Cell Therapy for People with HIV and B Cell Lymphoma

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Full Title

Axicabtagene Ciloleucel in Relapsed or Refractory HIV-Associated Aggressive B-Cell Non-Hodgkin Lymphoma (AMC-112) (CIRB)

Purpose

This study is assessing axicabtagene clioleucel CAR T cell therapy for people with HIV-related aggressive B cell lymphoma. The people in this study have B cell non-Hodgkin lymphoma that has come back or keeps growing after treatment, including:

  • Diffuse large B cell lymphoma
  • High-grade B cell lymphoma
  • Primary mediastinal B cell lymphoma
  • Follicular lymphoma grade 3B

T cells are immune cells that can kill tumor cells. Axicabtagene ciloleucel is made of genetically modified T cells that were altered in a lab to recognize CD19. The CD19 protein is on the surface of B cell cancer cells. 

Axicabtagene ciloleucel is given once intravenously (by vein). You will also get cyclophosphamide and fludarabine to prepare your body for the CAR T cell therapy.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have HIV-related B cell lymphoma that is growing within 12 months of your last treatment OR has come back after at least 2 prior regimens of lymphoma therapy.
  • Have a viral load of HIV below 50 copies/mL within 6 months of registering for the study.
  • Have recovered from the serious side effects of previous lymphoma treatments.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. M. Lia Palomba’s office at 646-608-3711.

Protocol

24-129

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

ClinicalTrials.gov ID

NCT05077527