Trial Title:
A Study to Investigate LYL845 in Adults With Solid Tumors
NCT ID:
NCT05573035
Condition:
Melanoma
Non-small Cell Lung Cancer
Colorectal Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Melanoma
Conditions: Keywords:
TIL
tumor infiltrating lymphocyte
melanoma
non-small cell lung cancer
colorectal cancer
NSCLC
CRC
relapsed
refractory
locally advanced
advanced
metastatic
epigenetic
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single-arm, open-label, dose-escalation and -expansion study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
LYL845
Description:
LYL845 is an autologous tumor infiltrating lymphocyte (TIL) enhanced via Epi-R, a
proprietary epigenetic reprogramming technology
Arm group label:
Experimental LYL845
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).
Detailed description:
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). During the dose-escalation phase of the study (Part
A), participants with melanoma will be enrolled. Once a safe recommended Phase 2 dose
range (RP2DR) has been established in Part A, enrollment will be expanded (Part B) to
include additional participants with melanoma, NSCLC and CRC.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
UC Davis Coomprehensive Cancer Center
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Facility:
Name:
UCLA Medical Center
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Facility:
Name:
Stanford University
Address:
City:
Stanford
Zip:
94305
Country:
United States
Facility:
Name:
Yale Cancer Center, Yale University
Address:
City:
New Haven
Zip:
06511
Country:
United States
Facility:
Name:
Georgetown University
Address:
City:
Washington
Zip:
20007
Country:
United States
Facility:
Name:
University of Iowa Hospitals and Clinics
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Facility:
Name:
Mayo Clinic Comprehensive Cancer Center
Address:
City:
Rochester
Zip:
55905
Country:
United States
Facility:
Name:
Hackensack Meridian Health Inc
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Facility:
Name:
Ohio State University Medical Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Facility:
Name:
Oregon Health Sciences University
Address:
City:
Portland
Zip:
97239
Country:
United States
Facility:
Name:
Allegheny General Hospital
Address:
City:
Pittsburgh
Zip:
15224
Country:
United States
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75235
Country:
United States
Facility:
Name:
Huntsman Cancer Institute at University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Start date:
December 19, 2022
Completion date:
September 2027
Lead sponsor:
Agency:
Lyell Immunopharma, Inc.
Agency class:
Industry
Source:
Lyell Immunopharma, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05573035
