A Phase 1/2 Study of OBX-115 Cell Therapy and Acetazolamide in People With Advanced Melanoma or Lung Cancer

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Full Title

A Phase 1/2, Open-Label Study to Investigate the Safety and Efficacy of Membrane Bound IL-15 Expressing Tumor-Infiltrating Lymphocytes (OBX-115) In Participants with Advanced Solid Tumors

Purpose

The purpose of this study is to assess OBX-115 cellular therapy for people with advanced melanoma or lung cancer. The people in this study have melanoma or non-small cell lung cancer (NSCLC). Their cancers have metastasized (spread) or are inoperable (cannot be taken out with surgery) and keep growing even after treatment.

OBX-115 is a personalized cellular therapy that will be made specifically for each participant. It is a form of tumor-infiltrating lymphocyte (TIL) therapy. We will collect a sample of cells from your tumor and send it to a laboratory. There the cells will be genetically modified (changed) to make OBX-115. This treatment is designed to activate and train your immune system to find and kill cancer cells.

Acetazolamide is a drug that can enter cells easily because of its small size. Giving acetazolamide with OBX-115 may help OBX-115 find and kill cancer cells. OBX-115 is given intravenously (by vein) and acetazolamide is taken orally (by mouth).

Who Can Join

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

  • Have metastatic or inoperable melanoma or NSCLC that keeps growing after treatment.
  • Have had prior treatment with immunotherapy medication.
  • Be willing to relocate to the New York City area for the study therapy.
  • Have recovered from the serious side effects of prior therapies before getting the study treatment.
  • 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 and to see if you can join this study, please call Dr.  Alexander Shoushtari’s office at 646-888-4161.

Protocol

24-057

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory

ClinicalTrials.gov ID

NCT06060613