Recruiting
Phase 1
Phase 2

GCC19CART

Sponsor:

Lyell Immunopharma, Inc.

Code:

NCT05319314

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LYL273

Study Details

Brief summary:

This is a Phase 1/2 open-label, multicenter study evaluating the safety and efficacy of LYL273 in participants with relapsed or refractory metastatic colorectal cancer.

Conditions

Colorectal Cancer

Study ID

NCT05319314

Start date

Aug 1, 2022

Status verified date

Jun, 2026

Completion date

Jun, 2032

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Other protocol defined Inclusion/Exclusion criteria may apply

Study Design

Enrollment

155 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LYL273

Single infusion of LYL273 at the dose assigned to an individual participant.

All participants will receive the same investigational therapy with the dose administered dependent upon the dose level they are assigned to in a sequential manner.

Interventions

LYL273

Single infusion of Chimeric Antigen Receptor (CAR) transduced autologous T cells administered intravenously (i.v.)

Primary outcome measure

  • Phase 1: Incidence of adverse events (AEs) defined as dose-limiting toxicities (DLTs) during 3+3 dose escalation study [ Time Frame: Infusion (Day 0) to Day 28 ]
  • Phase 1: Maximum tolerable dose (MTD) based on incidence of dose-limiting toxicities (DLTs) during 3+3 dose escalation study [ Time Frame: Infusion (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 study [ Time Frame: Infusion (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 criteria [ Time Frame: Baseline to Month 18 ]

Central Contacts and Locations

Locations

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Jessica Mathias

626-218-4088jmathias@coh.org

Kimberly Le

626-218-2997kimle@coh.org

University of California San Francisco Medical Center

Recruiting

San Francisco, California, United States, 94143

Contacts

UCSF Team

415-818-4579HDFCCC.CIP@ucsf.edu

University of Colorado Hospital - Anschutz Cancer Pavilion

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Meredith Waring

303-724-9840meredith.waring@cuanschutz.edu

Alexander Pung

303-724-9632alexander.pung@cuanschutz.edu

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215-5418

Contacts

Jamie Dela Cruz

857-215-2833jamiep_delacruz@dfci.harvard.edu

More Information

Sponsor

Lyell Immunopharma, Inc.

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • relapsed metastatic colorectal cancer
  • refractory metastatic colorectal cancer
  • chimeric antigen receptors (CAR)
  • colorectal cancer
  • metastatic colorectal cancer
  • mCRC
  • CAR T-cell
  • guanylyl cyclase C
  • GCC
  • colorectal neoplasms
  • autologous T cells

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Lyell Immunopharma, Inc. on 2026-06-09.