LYL845 for Solid Cancers

Recruiting in Palo Alto (17 mi)

+17 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Lyell Immunopharma, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

Adults aged 18-75 with advanced melanoma, NSCLC, or CRC that's relapsed/refractory after prior treatments can join. They need at least one resectable tumor lesion and must use effective contraception. Exclusions include other cancers within 3 years, certain blood thinners, pregnancy/nursing, uncontrolled effusions/ascites, active autoimmune diseases or infections, high-dose steroids (>10 mg prednisone/day), previous cell therapy or organ transplants.

Inclusion Criteria

I am fully active or can carry out light work.

I have a cancer lesion that can be removed and another that can be measured and biopsied.

I am capable of becoming pregnant and have a negative pregnancy test.

+6 more

Exclusion Criteria

I have had cell therapy treatment before.

I have fluid buildup in my chest or abdomen that causes symptoms.

I have not had any other cancer within the last 3 years.

+8 more

Participant Groups

LYL845 is being tested in this study to see if it's safe and works against tumors. It's a new type of TIL therapy for adults who've had their cancer come back or not respond to treatment. The trial involves increasing doses to find the right amount and will also look at how well it shrinks tumors in participants with melanoma, NSCLC, and CRC.

1Treatment groups

Experimental Treatment

Group I: Experimental LYL845Experimental Treatment1 Intervention

Epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy