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CAR T-cell Therapy
Lifileucel for Melanoma (LN-144 Trial)
Phase 2
Waitlist Available
Research Sponsored by Iovance Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have adequate organ function: Serum alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (SGPT) and aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) ≤ 3 times the upper limit of normal (ULN); patients with liver metastasis ≤ 5 times ULN, Estimated creatinine clearance (eCrCl) ≥ 40 mL/min using the Cockcroft-Gault formula, Total bilirubin ≤ 2 mg/dL, Patients with Gilbert's syndrome must have a total bilirubin ≤ 3 mg/dL
Patients with unresectable or metastatic melanoma (Stage IIIc or Stage IV)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
Awards & highlights
LN-144 Trial Summary
This trial is testing a new cancer treatment that uses the patient's own immune cells to fight the cancer.
Who is the study for?
Adults over 18 with metastatic melanoma who've had at least one systemic therapy, including a PD-1 blocking antibody. They must have good organ function, not be pregnant or breastfeeding, and can't have certain medical conditions like severe heart disease or untreated brain metastases. Participants need to agree to use effective birth control.Check my eligibility
What is being tested?
The trial is testing Lifileucel (LN-144), which are T cells from the patient's own tumor, given after chemotherapy that doesn't destroy bone marrow. The goal is to see if these cells can fight cancer when followed by interleukin 2 (IL-2), a substance that activates immune cells.See study design
What are the potential side effects?
Potential side effects include reactions related to the infusion of T cells and IL-2 such as flu-like symptoms, fatigue, rash, itching, headache, digestive issues and could also affect how organs like the liver and kidneys work.
LN-144 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver and kidney functions are within the required ranges.
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My melanoma cannot be removed by surgery and is advanced.
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My cancer progressed after treatment with a PD-1 inhibitor and, if applicable, a BRAF inhibitor.
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I have a tumor that can be surgically removed and is at least 1.5 cm in size.
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I haven't had cancer treatment for at least 28 days before starting the new therapy.
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I can care for myself and doctors expect me to live at least 3 more months.
LN-144 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease Assessment for Objective Response Rate
Secondary outcome measures
Adverse Events
Disease Assessment for Disease Control Rate
Disease Assessment for Duration of Response
+2 moreLN-144 Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment1 Intervention
Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)
Group II: Cohort 3Experimental Treatment1 Intervention
Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b).
Group III: Cohort 2Experimental Treatment1 Intervention
Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)
Group IV: Cohort 1Experimental Treatment1 Intervention
Lifileucel (LN-144) without cryopreservation (Gen 1 infusion product) (Closed)
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Who is running the clinical trial?
Iovance Biotherapeutics, Inc.Lead Sponsor
20 Previous Clinical Trials
1,518 Total Patients Enrolled
9 Trials studying Melanoma
781 Patients Enrolled for Melanoma
Iovance Biotherapeutics Medical MonitorStudy ChairIovance Biotherapeutics, Inc.
3 Previous Clinical Trials
312 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 28 days.I am over 60 with heart issues and have passed a cardiac stress test without any permanent heart wall movement problems.I am 18 years or older.My liver and kidney functions are within the required ranges.I have had an organ transplant or cell therapy before.My melanoma originates from the eye.I haven't had any cancer except for certain skin, breast, cervical, or prostate cancers in the last 3 years.My melanoma cannot be removed by surgery and is advanced.My cancer progressed after treatment with a PD-1 inhibitor and, if applicable, a BRAF inhibitor.I have a tumor that can be surgically removed and is at least 1.5 cm in size.I have recovered from previous treatment side effects, except for hair loss or skin changes.I had severe diarrhea or colitis from past immune therapy but have been symptom-free for 6 months or had a normal colonoscopy.I understand the study's requirements, have signed the consent form, and agree to follow the study rules and attend all required visits.My cancer has a BRAF mutation, and I haven't been treated with BRAF or MEK inhibitors.I am on long-term steroid medication for a health condition.Your blood tests must show that you have enough white blood cells, red blood cells, and platelets.You have a lung function test showing that you can't breathe out a lot of air in one second.I haven't had cancer treatment for at least 28 days before starting the new therapy.You have a condition that weakens your immune system, like severe combined immunodeficiency disease or acquired immunodeficiency syndrome (AIDS).I am able to give consent and am not under any legal or medical constraints that would prevent me from doing so.You have at least one specific spot that can be measured to see how the treatment is working.I can care for myself and doctors expect me to live at least 3 more months.I have brain metastases that are either causing symptoms or have not been treated.My heart's pumping ability is reduced, or I have slight limitations on physical activity.You have had a bad reaction to any part of the LN-144 treatment or other drugs being studied.I do not have any active illnesses that could increase my risk in this study.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 4
- Group 2: Cohort 2
- Group 3: Cohort 3
- Group 4: Cohort 1
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What safety precautions should be taken when utilizing Lifileucel?
"Since Lifileucel is only in a Phase 2 trial, Power gives it an estimated safety rating of 2. This means there is some evidence indicating its security but no studies that verify the efficacy of this medication yet."
Answered by AI
Is enrollment still open for this investigation?
"The clinical trial registry hosted on clinicaltrials.gov reveals that patient recruitment for this study has ceased; the original posting was made in September 2015 and it underwent its most recent update March 2021. Despite this, there remain 765 other studies across varying disciplines accepting patients at present."
Answered by AI
How widely is this experiment accessible to patients?
"Currently, 23 different clinical trial sites are enrolling patients with the James Graham Brown Cancer Center in Louisville, Yale Cancer Center in New Haven, and Indiana University in Indianapolis being some of the prominent locations."
Answered by AI
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