A Study to Investigate LYL797 in Adults With Solid Tumors


About this study

The purpose of this study is to evaluate the safety and tolerability of LYL797, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ relapsed or refractory triple negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC). The first part of the study will determine the safe dose for the next part of the study, and will enroll TNBC patients only. The second part of the study will test that dose in additional TNBC patients and NSCLC patients.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- ≥ 18 years of age at time of informed consent

- Histologically confirmed TNBC or NSCLC that is relapsed or refractory, metastatic or
locally advanced and unresectable that is ROR1+ by central laboratory
immunohistochemistry (IHC)

- Measurable disease including a target lesion and an additional lesion for biopsy

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Adequate organ and marrow function

- Women of childbearing potential must have a negative pregnancy test at screening

- All participants must agree to practice highly effective methods of contraception

Exclusion Criteria:

- Prior treatment with any adoptive T-cell therapy or anti-ROR1 therapy

- Prior solid organ transplantation

- Active, untreated brain metastasis or leptomeningeal disease; stable, treated brain
involvement by disease is allowed

- Untreated or active infection at the time of screening or leukapheresis

- HIV-positive, HTLV-1-positive, active acute or chronic HBV or HCV, or active

- Impaired cardiac function or clinically significant cardiac disease

- Uncontrolled pleural or pericardial effusion

- Systemic corticosteroids or other immunosuppressive medications within 14 days of

- Required chronic anticoagulation, such as warfarin, low molecular weight heparin, or
Factor Xa inhibitors

- Pregnant or lactating/nursing women

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 5/4/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Hemant Murthy, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Roberto Leon Ferre, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Brenda Ernst, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


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