A Study to Investigate LYL797 in Adults With Solid Tumors

This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring CAR T-cell therapy, CAR T, CAR T-cell, CAR-T, CAR-T cell therapy, CAR-T cell, ROR1, ROR1+, ROR1 positive, cell therapy, immunotherapy, relapsed, refractory, solid tumor, advanced, metastatic, breast cancer, lung cancer, triple negative breast cancer, non small cell lung cancer Read More

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 tuberculosis
• Impaired cardiac function or clinically significant cardiac disease
• Uncontrolled pleural or pericardial effusion
• Systemic corticosteroids or other immunosuppressive medications within 14 days of leukapheresis
• Required chronic anticoagulation, such as warfarin, low molecular weight heparin, or Factor Xa inhibitors
• Pregnant or lactating/nursing women