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Purpose

This is an open-label, multi-center, dose-escalation study with expansion cohorts, designed to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC).

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥ 18 years up to ≤ 75 years at the time of informed consent - Confirmed diagnosis of melanoma, non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) that is metastatic or locally advanced or unresectable and is relapsed and/or refractory (R/R) after standard therapy for each tumor histology - Participants must have received prior systemic treatment for their metastatic disease or locally advanced disease based on tumor type as follows: - Melanoma: participants with disease progression following an immune checkpoint inhibitor (CPI) - NSCLC: participants with disease progression following at least 1 approved systemic therapy, including an immune CPI-containing regimen for appropriate patients or an approved targeted therapy for known molecular abnormalities if applicable to their disease - CRC: participants with disease progression following at least 1 line of therapy, including a fluoropyrimidine with oxaliplatin or irinotecan. Microsatellite instability (MSI) high/mismatch repair deficient (dMMR) CRC participants must have disease progression following systemic therapy with immune CPIs. - Measurable disease including at least 1 lesion that is safely resectable AND a target lesion to measure response and an additional lesion for biopsy - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Adequate organ and marrow function - Women of childbearing potential must have a negative pregnancy test at screening - All participants must agree to practice highly effective methods of contraception - Fully recovered from toxicity from prior systemic anticancer therapy

Exclusion Criteria

  • Prior treatment with adoptive cellular therapy - Prior solid organ transplantation - Central nervous system (CNS) involvement of disease that is extensive, symptomatic or untreated, or patients with leptomeningeal disease - Uncontrolled or symptomatic pleural effusion or ascites - Untreated or active systemic infection - Active autoimmune disease requiring treatment or primary immunodeficiency syndrome - Systemic corticosteroids at a dose of >10 mg of prednisone or equivalent per day - Other primary malignancy within 3 years prior to enrollment - Impaired cardiac function or clinically significant cardiovascular disease - Required chronic anticoagulation, such as warfarin, low molecular weight heparin, or Factor Xa inhibitors - Pregnant or nursing (lactating) women

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Single-arm, open-label, dose-escalation and -expansion study
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Experimental LYL845 		Epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy
  • Biological: LYL845
    LYL845 is an autologous tumor infiltrating lymphocyte (TIL) enhanced via Epi-R, a proprietary epigenetic reprogramming technology

More Details

Status
Active, not recruiting
Sponsor
Lyell Immunopharma, Inc.

Study Contact

Detailed Description

This is an open-label, multi-center, dose-escalation study with expansion cohorts, designed to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). During the dose-escalation phase of the study (Part A), participants with melanoma will be enrolled. Once a safe recommended Phase 2 dose range (RP2DR) has been established in Part A, enrollment will be expanded (Part B) to include additional participants with melanoma, NSCLC and CRC.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.