Open
Actively Recruiting
A Study to Investigate LYL845 in Adults With Solid Tumors
About
Brief Summary
This is an open-label, multi-center, dose-escalation study with expansion cohorts, designed to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC).
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- Age ≥ 18 years up to ≤ 75 years at the time of informed consent
- Confirmed diagnosis of melanoma, non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) that is metastatic or locally advanced or unresectable and is relapsed and/or refractory (R/R) after standard therapy for each tumor histology
- Participants must have received prior systemic treatment for their metastatic disease or locally advanced disease based on tumor type as follows:
- Melanoma: participants with disease progression following an immune checkpoint inhibitor (CPI)
- NSCLC: participants with disease progression following at least 1 approved systemic therapy, including an immune CPI-containing regimen for appropriate patients or an approved targeted therapy for known molecular abnormalities if applicable to their disease
- CRC: participants with disease progression following at least 1 line of therapy, including a fluoropyrimidine with oxaliplatin or irinotecan. Microsatellite instability (MSI) high/mismatch repair deficient (dMMR) CRC participants must have disease progression following systemic therapy with immune CPIs.
- Measurable disease including at least 1 lesion that is safely resectable AND a target lesion to measure response and an additional lesion for biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status of 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
- Fully recovered from toxicity from prior systemic anticancer therapy
Exclusion Criteria:
- Prior treatment with adoptive cellular therapy
- Prior solid organ transplantation
- Central nervous system (CNS) involvement of disease that is extensive, symptomatic or untreated, or patients with leptomeningeal disease
- Uncontrolled or symptomatic pleural effusion or ascites
- Untreated or active systemic infection
- Active autoimmune disease requiring treatment or primary immunodeficiency syndrome
- Systemic corticosteroids at a dose of >10 mg of prednisone or equivalent per day
- Other primary malignancy within 3 years prior to enrollment
- Impaired cardiac function or clinically significant cardiovascular disease
- Required chronic anticoagulation, such as warfarin, low molecular weight heparin, or Factor Xa inhibitors
- Pregnant or nursing (lactating) women
Join this Trial
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Study Stats
Protocol No.
23-000065
Category
Colorectal Cancer
Lung Cancer
Melanoma (Skin Cancer)
Other Cancer
Principal Investigator
Contact
Location
- UCLA Santa Monica
- UCLA Westwood