A Phase 1/2 interventional study of LYL273 in Colorectal Cancer, sponsored by Lyell Immunopharma, Inc.. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Lyell Immunopharma, Inc. · Phase 1/2, Interventional, and 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.
LYL273-101 (CARABiNER) is a Phase 1/2 open label, multicenter study evaluating the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of LYL273, a GCC-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release, in participants with relapsed or refractory metastatic colorectal cancer (mCRC).
The study may enroll multiple dose expansion cohorts at the Sponsor's discretion to further characterize the safety, feasibility, and preliminary antitumor activity of LYL273 under defined treatment conditions including those defined below.
Cohorts to explore alternative mCRC patient populations
Expansion cohorts may enroll a broader array of the mCRC population as listed below:
Up to 18 participants will be enrolled into each expansion cohort with up to approximately 95 patients enrolled in the Phase 1 portion of the study.
The Phase 2 portion of the study will expand enrollment at the recommended Phase 2 dose of approximately 60 additional patients.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 155 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Lyell Immunopharma, Inc. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply
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.
Drug: LYL273
Single infusion of Chimeric Antigen Receptor (CAR) transduced autologous T cells administered intravenously (i.v.)
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
Phase 1 and 2: Evaluate the efficacy of LYL273
ORR based on investigator assessment per RECIST Version 1.1 criteria
Time frame: Infusion (Day 0) until the date of first documented confirmed complete or partial response per RECIST Version 1.1 criteria, assessed up to 18 months
Phase 1 and 2: Evaluate the efficacy of LYL273
Duration of response (DOR) based on Investigator assessment per RECIST Version 1.1 criteria.
Time frame: Date of first documented confirmed complete or partial response per RECIST Version 1.1 criteria until the date of disease progression or recurrence or date of death whichever comes first
Phase 1 and 2: Evaluate the efficacy of LYL273
Time to response based on Investigator assessment per RECIST Version 1.1 criteria.
Time frame: Infusion (Day 0) until the date of first documented confirmed complete or partial response per RECIST Version 1.1 criteria, assessed up to 18 months
Phase 2: Evaluate the efficacy of LYL273
Duration of response based on IRC assessment per RECIST Version 1.1 criteria
Time frame: Date of first documented confirmed complete or partial response per RECIST Version 1.1 criteria until the date of disease progression or recurrence or date of death whichever comes first
Phase 2: Evaluate the efficacy of LYL273
Time to response based on IRC assessment per RECIST Version 1.1 criteria
Time frame: Infusion (Day 0) until the date of first documented confirmed complete or partial response per RECIST Version 1.1 criteria, assessed up to 18 months
Phase 1 and 2: Evaluate the efficacy of LYL273
Progression free survival (PFS) based on Investigator assessment per RECIST Version 1.1 criteria
Time frame: Infusion (Day 0) until the date of first documented progression/recurrence or date of death from any cause, whichever comes first
Phase 1 and 2: Overall Survival (OS)
Overall survival (OS)
Time frame: Infusion (Day 0) until date of death from any cause
Phase 2: Incidence and severity of adverse events
Time frame: Infusion (Day 0) to 3 months
Phase 1 and 2: Cellular Kinetics
Maximum concentration (Cmax), time to peak cell expansion (Tmax), area under the concentration curve from time 0 to Day 28 (AUC0-28), and cellular persistence (time of last measurable concentration \[Tlast\]) for the GCC CAR T cells
Time frame: Infusion (Day 0) up to 18 months
Plan to share: No
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Lyell Immunopharma, Inc.