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TerminatedPhase 1NCT05573035
Official study title

A Study to Investigate LYL845 in Adults With Solid Tumors

Study 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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLYL845

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 1, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?18 U.S. locations

Locations may change over time.

Who runs it?Lyell Immunopharma, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Lyell Immunopharma, Inc.
Interventions being studied
Biological: LYL845
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→Metastatic or stage IV→Recurrent or relapsed→Resistant or refractory→
Treatment approach
Cell or gene therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • UC Davis Coomprehensive Cancer CenterSacramento, California
  • UCLA Medical CenterSanta Monica, California
  • Stanford UniversityStanford, California
  • Yale Cancer Center, Yale UniversityNew Haven, Connecticut
  • Georgetown UniversityWashington D.C., District of Columbia
  • University of Iowa Hospitals and ClinicsIowa City, Iowa
  • Massachusetts General HospitalBoston, Massachusetts
  • Dana-Farber Cancer InstituteBoston, Massachusetts
  • Mayo Clinic Comprehensive Cancer CenterRochester, Minnesota
  • Hackensack Meridian Health IncHackensack, New Jersey
  • Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey
  • Duke University Medical CenterDurham, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 1, 2025. Always confirm current availability with the study team.

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