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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
LYL845 is an autologous tumor infiltrating lymphocyte (TIL) enhanced via Epi-R, a proprietary epigenetic reprogramming technology
UC Davis Coomprehensive Cancer Center
Sacramento, California, United States
UCLA Medical Center
Santa Monica, California, United States
Incidence of dose-limiting toxicities (DLTs)
Evaluate incidence of dose-limiting toxicities (DLTs)
Time frame: Up to 28 days
Incidence of treatment-emergent adverse events (TEAEs)
Evaluate incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 years
Severity of treatment-emergent adverse events (TEAEs)
Evaluate severity of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 years
Determine recommended Phase 2 Dose Range (RP2DR)
Determine the recommended Phase 2 dose range (during dose-escalation phase)
Time frame: Up to 2 years
Overall response rate (ORR) by RECIST, version 1.1
Evaluate anti-tumor activity of LYL845 based on overall response rate (ORR) by RECIST, version 1.1
Time frame: up to 2 years
Duration of response (DOR)
Evaluate duration of response (DOR)
Time frame: up to 2 years
Progression-free survival (PFS)
Evaluate progression-free survival (PFS)
Time frame: up to 2 years
Overall survival (OS)
Evaluate overall survival (OS)
Time frame: up to 2 years
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Stanford University
Stanford, California, United States
Yale Cancer Center, Yale University
New Haven, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
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Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
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Mayo Clinic Comprehensive Cancer Center
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Hackensack Meridian Health Inc
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