Suspended

A Phase 1 Study to Assess the Safety and Efficacy of LYL845 in Adults With Relapsed and/or Refractory Metastatic or Locally Advanced Melanoma and Selected Solid Tumor Malignancies

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What is being tested

LYL845

Biological
Who is being recruted

Bronchial Neoplasms+32

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

From 18 to 75 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: December 2022
See protocol details

Summary

Principal SponsorLyell Immunopharma, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 19, 2022

Actual date on which the first participant was enrolled.

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.

Official TitleA Phase 1 Study to Assess the Safety and Efficacy of LYL845 in Adults With Relapsed and/or Refractory Metastatic or Locally Advanced Melanoma and Selected Solid Tumor Malignancies
NCT05573035
Principal SponsorLyell Immunopharma, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

39 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungColonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsLung DiseasesLung NeoplasmsMelanomaNeoplasm MetastasisNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNeoplastic ProcessesPathologic ProcessesRectal DiseasesRecurrenceRespiratory Tract DiseasesRespiratory Tract NeoplasmsSkin DiseasesSkin NeoplasmsPathological Conditions, Signs and SymptomsThoracic NeoplasmsColorectal NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine TumorsDisease Attributes

Criteria

12 inclusion criteria required to participate
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)
Show More Criteria
11 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 18 locations

Suspended

Hackensack Meridian Health Inc

Hackensack, United StatesOpen Hackensack Meridian Health Inc in Google Maps
Suspended

UC Davis Coomprehensive Cancer Center

Sacramento, United States
Suspended

UCLA Medical Center

Santa Monica, United States
Suspended

Stanford University

Stanford, United States
Suspended18 Study Centers