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Tumor Infiltrating Lymphocyte Therapy
LYL845 for Solid Cancers
Phase 1
Waitlist Available
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
No Placebo-Only Group
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determine recommended Phase 2 Dose Range (RP2DR)
Incidence of dose-limiting toxicities (DLTs)
Therapeutic procedure
+1 moreSecondary study objectives
Duration of response (DOR)
Overall response rate (ORR) by RECIST, version 1.1
Overall survival (OS)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
350 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cell therapy treatment before.I have fluid buildup in my chest or abdomen that causes symptoms.I am fully active or can carry out light work.I have not had any other cancer within the last 3 years.I have a cancer lesion that can be removed and another that can be measured and biopsied.I currently have an untreated or active infection.I am capable of becoming pregnant and have a negative pregnancy test.I am between 18 and 75 years old.I am taking more than 10 mg of prednisone or its equivalent daily.I have heart problems or significant heart disease.I have no lingering side effects from previous cancer treatments.My cancer (melanoma, NSCLC, or CRC) is advanced, cannot be surgically removed, and has not responded to standard treatments.I am on long-term blood thinners like warfarin.I have had a solid organ transplant.My cancer has spread to my brain or spinal cord and is either widespread, causing symptoms, or not treated.My organs and bone marrow are working well.I am receiving treatment for an autoimmune disease or have a primary immunodeficiency.My melanoma worsened after CPI treatment and, if BRAF-mutated, after BRAF/MEK inhibitor therapy.My NSCLC worsened after treatment, including immunotherapy or targeted therapy if it was suitable.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental LYL845
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.