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Tumor Infiltrating Lymphocyte Therapy

LYL845 for Solid Cancers

Phase 1
Recruiting
Research Sponsored by Lyell Immunopharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial will test a new cancer therapy for people with melanoma, lung cancer and colorectal cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects of LYL845 may include typical reactions related to immune therapies such as inflammation in different body parts (like colitis), fatigue, skin reactions (like rash), flu-like symptoms including fever and chills; specific side effects are not listed but generally align with those expected from cellular immunotherapies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine recommended Phase 2 Dose Range (RP2DR)
Incidence of dose-limiting toxicities (DLTs)
Therapeutic procedure
+1 more
Secondary outcome measures
Duration of response (DOR)
Overall response rate (ORR) by RECIST, version 1.1
Overall survival (OS)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental LYL845Experimental Treatment1 Intervention
Epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy

Find a Location

Who is running the clinical trial?

Lyell Immunopharma, Inc.Lead Sponsor
2 Previous Clinical Trials
304 Total Patients Enrolled

Media Library

LYL845 (Tumor Infiltrating Lymphocyte Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05573035 — Phase 1
Melanoma Research Study Groups: Experimental LYL845
Melanoma Clinical Trial 2023: LYL845 Highlights & Side Effects. Trial Name: NCT05573035 — Phase 1
LYL845 (Tumor Infiltrating Lymphocyte Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05573035 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What safety protocols have been implemented to ensure the usage of Experimental LYL845 is not detrimental?

"Our team's assessment of the safety profile of Experimental LYL845 is a 1 due to its phase 1 status, which indicates that there is limited data available on both efficacy and safety."

Answered by AI

Am I eligible to partake in this research project?

"This clinical trial is accepting 108 individuals diagnosed with colorectal carcinoma, aged between 18 and 75. Participants must meet the following requirements: have attained age of consent or be older, possess a verified diagnosis of melanoma, non-small cell lung cancer (NSCLC), or colorectal cancer that has metastasized/is locally advanced/cannot be surgically removed, demonstrate measurable disease along with an accessible lesion to measure response and another for biopsy purposes, present ECOG performance status 0 or 1; show adequate organ & marrow function; female subjects should perform pregnancy test prior to admission; all participants need"

Answered by AI

What are the anticipated outcomes of this investigation?

"According to the sponsor of this trial, Lyell Immunopharma, Inc., its primary goal is to Determine recommended Phase 2 Dose Range (RP2DR) over a two year period. Additionally, secondary objectives include evaluation of anti-tumor activity via Complete response rate (CR) by RECIST version 1.1 , assessment of Overall survival (OS), and T-cell phenotype assay using flow cytometry and RNA expression profiling for LYL845."

Answered by AI

Are there several venues across Canada which are hosting this trial?

"Four medical centres are currently participating in this research initiative, such as the Huntsman Cancer Institute at University of Utah in Salt Lake City, Allegheny General Hospital in Pittsburgh, and Oregon Health Sciences University in Portland. Additionally, there is a quartet of other locations available for enrolment."

Answered by AI

Is eligibility for this medical study restricted to a particular age group?

"As per the parameters outlined in the eligibility criteria, would-be participants of this clinical trial must be between 18 and 75 years old."

Answered by AI

Are there still opportunities to join this research project?

"This research, first posted on December 1st 2022 and last revised October 11th of the same year, is no longer in search of participants. Nonetheless, there are 3,054 other medical trials that are actively seeking enrollees at this moment."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
UCLA Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
~52 spots leftby Aug 2025