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

Principal Investigator

Yazan Migdady

Study Purpose

The purpose of this research study is to test whether LYL797, an investigational cell product, is safe at different doses. The study will try to find the optimal dose of LYL797 for further research. Another goal is to see if the study cells are able to kill cancer cells in participants who have non-small cell lung cancer or breast cancer that has come back after previous treatment (relapsed), or did not respond to previous treatment (refractory). To be eligible, participants cancer must have a protein in the cancer cells called ROR1.

LYL797 is made up of immune cells collected from the participant and then are genetically engineered.

Medical Condition(s)

Non-small cell lung cancer (NSCLC)
Triple-negative breast cancer (TNBC)

Eligibility Criteria

- Age over 18 years
- Relapsed or refractory triple-negative breast cancer
- Relapsed or refractory non-small lung cell cancer
- Adequate organ function
- Willing to have a biopsy after the study cell administration

Cannot have:
- Cancer that has spread to the brain
- Prior organ transplant
- Active hepatitis B or C infection
- Heart disease

Age Range

18 - 120

Healthy Volunteers Needed


Duration of Participation

Participants will remain in this study for 2 years, and then asked to join a separate study that will last until 15 years after the study cell infusion

Minors Included



Clinical Trials Information Line


Lyell Immunopharma, Inc.

Recruitment End


Compensation Provided


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