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CAR T-cell Therapy
TIL Therapy for Cancer
Phase 2
Waitlist Available
Led By Amir A Jazaeri
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must have an area of tumor amenable to excisional biopsy (core biopsies may be allowed as detailed in protocol) for the generation of TIL separate from, and in addition to, a target lesion to be used for response assessment
Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1
Must not have
Various medical history and conditions including active viral hepatitis, left ventricular ejection fraction (LVEF) < 45%, history of prior adoptive cell therapies, persistent prior therapy-related toxicities greater than grade 2, and others
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a treatment using a patient's own immune cells to fight various cancers that haven't responded to other treatments or have come back. The immune cells are taken from the tumor, grown in a lab, and then reintroduced into the body to target and kill cancer cells. The study aims to see how well this approach works and how safe it is.
Who is the study for?
This trial is for adults aged 18-70 with specific types of cancer (ovarian, TNBC, thyroid, osteosarcoma or other bone/soft tissue sarcomas) that are resistant to treatment or have returned. Participants must have a tumor suitable for biopsy and meet certain health criteria like heart and lung function tests. They should not be HIV positive or have uncontrolled illnesses.
What is being tested?
The trial is testing LN-145 and LN-145-S1, which are therapies using the patient's own T-cells grown from their tumors to fight cancer. It examines how well these cells can target and destroy cancer cells in patients who haven't responded to standard treatments.
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs, fatigue, digestive issues due to therapy-related toxicity greater than grade 2 if previously experienced with immunotherapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can have a piece of my tumor removed for testing, separate from the main cancer area.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I do not have HIV.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe ongoing side effects from previous treatments, active hepatitis, heart issues, or a history of certain cell therapies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective response rate
Secondary study objectives
Overall survival
Progression free survival
Other study objectives
Duration of TIL persistence
Health Related Quality of Life
Immunological phenotype of LN-145 by multichannel flow cytometry
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Thyroid Cohort (LN-145)Experimental Treatment6 Interventions
Patients receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine IV over 15-30 minutes daily on days -5 to -1, autologous tumor infiltrating lymphocytes LN-145 IV over 45 minutes on day 0 and aldesleukin IV over 30 minutes on days 1-4 for up to 6 doses.
Group II: ICI Ovarian Cancer, Sarcomas, Triple Negative Breast Cancer (LN-145-S1, nivolumab)Experimental Treatment9 Interventions
Ipilimumab will be administered as a single dose prior to tumor resection. Nivolumab will be administered once prior to tumor resection. Patients receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine IV over 15-30 minutes daily on days -5 to -1, LN-145-S1 IV over 45 minutes on day 0 and aldesleukin IV over 30 minutes on days 1-4 for up to 6 doses. Within 12 weeks after receiving LN-145-S1, patients receive nivolumab IV over 30 minutes every 4 weeks in the absence of disease progression or unacceptable toxicity. The second dose will be administered prior to TIL administration and dosing will continue every 4 weeks and continued until unacceptable toxicity, progression, or start of another cancer therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2320
Ipilimumab
2014
Completed Phase 3
~3140
Nivolumab
2014
Completed Phase 3
~5220
Aldesleukin
2012
Completed Phase 4
~1620
Fludarabine
2012
Completed Phase 4
~1860
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common cancer treatments, particularly immunotherapies like LN-145 or LN-145-S1, work by harnessing the patient's immune system to target and destroy cancer cells. These therapies involve collecting and modifying the patient's T-cells to enhance their ability to recognize and kill tumor cells.
This personalized approach is crucial for cancer patients as it offers a targeted treatment option that can be more effective and potentially less harmful than traditional therapies, especially for those with cancers that have relapsed or are resistant to other treatments.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,045 Previous Clinical Trials
1,800,054 Total Patients Enrolled
Iovance Biotherapeutics, Inc.Industry Sponsor
23 Previous Clinical Trials
1,795 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,868 Previous Clinical Trials
41,010,807 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe ongoing side effects from previous treatments, active hepatitis, heart issues, or a history of certain cell therapies.I had severe diarrhea or colitis from past immunotherapy but have been symptom-free for 6 months or had a normal colonoscopy.I can have a piece of my tumor removed for testing, separate from the main cancer area.I stopped any cancer treatments 28 days before enrolling for TIL therapy, except with PI approval for palliative care.I do not have any severe ongoing illnesses that are not under control.My heart test (stress echo) results were normal, or I had an alternative heart check approved by a cardiologist.I am between 18 and 70 years old.Your recent heart test should not show signs of heart problems, and a specific measurement of your heart's electrical activity should be within a certain range.You can breathe out and take deep breaths normally, without any significant problems.Your blood and other body chemistry levels need to be within certain ranges.Different types of cancer have their own specific rules for who can participate in the study.I am fully active or restricted in physically strenuous activity but can do light work.Women who could become pregnant must have a negative pregnancy test within 7 days before joining the study.I do not have HIV.
Research Study Groups:
This trial has the following groups:- Group 1: ICI Ovarian Cancer, Sarcomas, Triple Negative Breast Cancer (LN-145-S1, nivolumab)
- Group 2: Thyroid Cohort (LN-145)
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.
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