A Phase 1 Study of LYL797 CAR T Cell Therapy in People With Breast Cancer or Lung Cancer


Full Title

A Phase 1 Study to Assess the Safety and Efficacy of LYL797, ROR1- Targeting CAR T Cells, in Adults with Relapsed and/or Refractory Solid-Tumor Malignancies


Researchers want to find the safest dose of LYL797 to treat triple-negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC). The people in this study have TNBC or NSCLC that keeps growing even after treatment. In addition, they have cancer that makes a protein called ROR1, which helps cancer grow.

LYL797 is made from your own white blood cells (T cells). T cells are immune system cells. Some types of cancer can block T cells from attacking cancer cells. If you join this study, we will collect some of your T cells and modify them in a lab. This helps your T cells find and kill cancer cells that make ROR1. These modified T cells are called chimeric antigen receptor (CAR) T cells. Treatments made from them are called CAR T cell therapies.

LYL797 is given intravenously (by vein). If you join this study, you will first get chemotherapy with cyclophosphamide and fludarabine intravenously. These two drugs briefly weaken (suppress) your immune system and prepare your body to receive LYL797.

Who Can Join

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

  • Have TNBC or NSCLC that is inoperable (cannot be taken out with surgery) or metastatic (has spread). In addition, the cancer keeps growing after treatment.
  • Have cancer that makes ROR1.
  • Have recovered from the serious side effects of previous therapies before taking LYL797.
  • 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.


For more information or to see if you can join this study, please call Dr. Roisin O’Cearbhaill’s office at 646-608-2091.




Phase I (phase 1)

Disease Status

Relapsed or Refractory



ClinicalTrials.gov ID