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LYL273 for Relapsed or Refractory Metastatic Colorectal Cancer

This study is testing a new treatment called LYL273 for people with metastatic colorectal cancer that has come back or not responded to previous treatments. LYL273 is a type of CAR T-cell therapy, where your own immune cells are specially modified to fight cancer. The study will look at how safe LYL273 is and how well it works. You may be able to join if you are an adult with metastatic colorectal cancer, have limited liver disease, and have already received certain prior therapies. The study is currently unclear on its recruitment status and plans to enroll about 155 participants.

Study design
This is a Phase 1/2 open-label study, meaning both you and your doctors will know which treatment you are receiving. It aims to enroll about 155 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured from the time of infusion (Day 0) to Day 28.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05319314

LYL273 for Patients With Relapsed or Refractory mCRC

Recruiting
PHASE1Ages 18+InterventionalTreatment
Lyell Immunopharma, Inc.
~155 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:LYL273

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: Incidence of adverse events (AEs) defined as dose-limiting toxicities (DLTs) during 3+3 dose escalation study
Measured over Infusion (Day 0) to Day 28
+3 more outcomes measured

Conditions

Colorectal Cancer

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Where it's being run

4 sites across 3 states
California2
Colorado1
Massachusetts1

Who to contact

Jessica Mathias
[email protected]
626-218-4088
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults \> 18 years old
Clinical and histopathological diagnosis of relapsed or refractory metastatic colorectal cancer
Eastern Cooperative Oncology Group performance status of 0 or 1
Limited liver disease (less than 7 lesions with largest lesion less than 3 cm)
No surgical options with curative intent
Received prior therapy with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy in the advanced or metastatic setting, an anti-vascular endothelial growth factor (anti-VEGF) biological therapy if not contraindicated, and if RAS wild-type an anti-epidermal growth factor receptor (anti-EGFR) therapy in a manner consistent with National Comprehensive Cancer Network (NCCN) guidelines. Treatment must have been discontinued for disease progression or intolerance to therapy
Have at least one extracranial measurable target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 standard

Exclusion

Participants with tumor lesion(s) in a location that may cause perforation of an organ or structure (such as the digestive tract, urinary bladder, or blood vessel) with LYL273 therapy
Active central nervous system (CNS) involvement by malignancy on magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT)
History of or active viral infection including human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with CNS involvement in the 2-year period leading up to the study enrollment
No active infectious diseases or comorbid conditions that would interfere with safety or data quality
Pregnant or breast-feeding women

What this trial measures

  • Phase 1: Incidence of adverse events (AEs) defined as dose-limiting toxicities (DLTs) during 3+3 dose escalation studyInfusion (Day 0) to Day 28
  • Phase 1: Maximum tolerable dose (MTD) based on incidence of dose-limiting toxicities (DLTs) during 3+3 dose escalation studyInfusion (Day 0) to Day 28
  • Phase 1: Recommended Phase 2 dose (RP2D) based on incidence of dose-limiting toxicities (DLTs) during 3+3 dose escalation studyInfusion (Day 0) to Day 28
  • Phase 2: Estimate the efficacy of LYL273, as measured by overall response rate (ORR) based on Independent Review Committee (IRC) assessment per Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 criteriaBaseline to Month 18