A Study to Investigate LYL797 in Adults With Solid Tumors
Sponsored by Lyell Immunopharma, Inc.
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 3 years ago
What is this trial about?
What are the participation requirements?
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