A Study to Investigate LYL845 in Adults With Solid Tumors

Overview

About this study

The purpose of this study is 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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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) and if BRAF-mutated, BRAF/MEK inhibition

- 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

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 10/30/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Konstantinos Leventakos, M.D., Ph.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20567314

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