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RecruitingPhase 1 / Phase 2

LYL273 for Patients With Relapsed or Refractory mCRC

A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of LYL273 in Patients With Relapsed or Refractory Metastatic Colorectal Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years, 15 years
  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "LYL273 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a conditioning chemotherapy regimen consisting of fludarabine and cyclophosphamide, administered once, 3 days before LYL273 infusion."
  • "Individual participants will remain in the active post-treatment follow-up (PTFU) period for up to 5 years."
  • "Participants will continue in long-term follow-up (LTFU) for 15 years from LYL273 treatment in a separate protocol."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe LYL273 is and how well it works. It is for adults with colon or rectal cancer that has spread and has come back or has not responded to treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18.
  • Have colon or rectal cancer that has spread and has come back or resisted treatment, confirmed by medical exams and tissue testing.
  • Be fully active or able to do light work, even if heavy activity is limited.
  • Have fewer than 7 cancer spots in the liver, with the largest smaller than 3 cm.
  • Have no surgery option that could cure the cancer.
  • Have had chemotherapy with fluoropyrimidine, oxaliplatin, and irinotecan for advanced or spreading cancer. Also have had anti-VEGF treatment, which targets blood vessel growth, unless unsafe. If the cancer has no RAS gene change, have had anti-EGFR treatment, which blocks growth signals, as recommended by treatment guidelines. Treatment must have stopped because the cancer grew or side effects were too hard to tolerate.
  • Have at least one tumor outside the skull that can be measured using the study’s rules.

Who can't join

  • Have a tumor where LYL273 treatment could cause a hole in an organ or blood vessel.
  • Have active cancer in the brain or spinal cord shown on an MRI or a CT scan with contrast dye.
  • Have a current or past viral infection, including HIV, hepatitis B, or hepatitis C.
  • Have had a brain or spinal cord disorder in the past 2 years, such as seizures, stroke or bleeding in the brain, dementia, brain swelling, problems with the brain’s balance center, or an immune disease affecting the brain or spinal cord.
  • Have an active infection or another health condition that could affect safety or the study’s results.
  • Be pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (4)

CA

CO

MA