Study on LYL273 for Patients with Relapsed or Hard-to-Treat Metastatic Colorectal Cancer
Sponsor: Lyell Immunopharma, Inc.
ClinicalTrials ID:NCT05319314
This clinical trial is testing a new treatment called LYL273 to see if it is safe and effective for patients with metastatic colorectal cancer that has returned or not responded to previous treatments.
Patient Parameters
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Program Overview
The study aims to evaluate the safety and effectiveness of a new treatment, LYL273, for patients with metastatic colorectal cancer that has either come back or not responded to previous treatments. LYL273 is a type of CAR T-cell therapy that targets specific cancer cells and is given after a short course of chemotherapy. The trial will involve multiple groups of patients to explore different treatment combinations and patient populations.
Description
This clinical trial, named LYL273-101 (CARABiNER), is a Phase 1/2 study that is open to participants at multiple locations. It is designed to test the safety, tolerability, and effectiveness of LYL273, a new CAR T-cell therapy that targets a specific marker on cancer cells. The treatment also includes a controlled release of cytokines, which are substances that can affect the immune system.
The study will include different groups of patients to explore various aspects of the treatment:
- Some groups will include patients who have had only one previous treatment for their cancer.
- Other groups will test LYL273 in combination with additional cancer treatments, like radiation therapy.
Up to 18 participants will be included in each group, with about 95 patients in the initial phase of the study. The second phase will include around 60 more patients at the recommended dose.
Participants will receive a single infusion of the modified T-cells after a short chemotherapy regimen. They will be monitored closely for up to 5 years after treatment and will continue to be followed for 15 years to track long-term effects.
Eligibility Criteria
Inclusion Criteria
- Adults over 18 years old.
- Diagnosed with metastatic colorectal cancer that has returned or not responded to treatment.
- Good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Limited liver involvement, with fewer than 7 liver lesions and the largest being less than 3 cm.
- No surgical options available to cure the cancer.
- Previously treated with specific chemotherapy and biological therapies as recommended by guidelines.
- Have at least one measurable tumor outside the brain.
Exclusion Criteria
- Tumors in locations that could cause organ damage with the treatment.
- Active cancer involvement in the brain or central nervous system.
- History of or current viral infections like HIV, hepatitis B, or hepatitis C.
- History of brain disorders or autoimmune diseases affecting the brain in the last 2 years.
- No active infections or other health conditions that could affect safety or study results.
- Pregnant or breastfeeding women.
Other specific criteria may apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| University of California San Francisco Medical Center | 94143 | San Francisco | California |
| University of Colorado Hospital - Anschutz Cancer Pavilion | 80045 | Aurora | Colorado |
| Dana-Farber Cancer Institute | 02215-5418 | Boston | Massachusetts |
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