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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
Any prior therapy directed at the malignant tumor, including radiation therapy, chemotherapy, and biologic/targeted agents must be discontinued at least 28 days prior to enrollment for preparing TIL therapy. Palliative therapy may be received during the screening period with principal investigator (PI) approval for lesions that are not expected to be used for TIL generation or as target lesions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial will test how well LN-145 or LN-145-S1 work in treating patients with ovarian cancer, triple negative breast cancer, anaplastic thyroid cancer, osteosarcoma, or other bone and soft tissue sarcomas that do not respond to treatment or that has come back.

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.Check my eligibility
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.See study design
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 below
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I can have a piece of my tumor removed for testing, separate from the main cancer area.
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I stopped any cancer treatments 28 days before enrolling for TIL therapy, except with PI approval for palliative care.
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My heart test (stress echo) results were normal, or I had an alternative heart check approved by a cardiologist.
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I am between 18 and 70 years old.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I do not have HIV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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
Objective response rate
Secondary outcome measures
Disease control rate
Duration of response
Incidence of adverse events of adoptive cell therapy with tumor infiltrating lymphocytes (TIL) across multiple tumor types
+2 more
Other outcome measures
Duration of TIL persistence
Health Related Quality of Life
Immunological phenotype of LN-145 by multichannel flow cytometry
+2 more

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
Ipilimumab
2014
Completed Phase 3
~2640
Cyclophosphamide
1995
Completed Phase 3
~3780
Nivolumab
2014
Completed Phase 3
~4750
Aldesleukin
2012
Completed Phase 4
~1620
Fludarabine
2012
Completed Phase 3
~1090

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,419 Total Patients Enrolled
Iovance Biotherapeutics, Inc.Industry Sponsor
20 Previous Clinical Trials
1,666 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,616 Total Patients Enrolled

Media Library

Autologous Tumor Infiltrating Lymphocytes LN-145 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03449108 — Phase 2
Cancer Research Study Groups: ICI Ovarian Cancer, Sarcomas, Triple Negative Breast Cancer (LN-145-S1, nivolumab), Thyroid Cohort (LN-145)
Cancer Clinical Trial 2023: Autologous Tumor Infiltrating Lymphocytes LN-145 Highlights & Side Effects. Trial Name: NCT03449108 — Phase 2
Autologous Tumor Infiltrating Lymphocytes LN-145 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03449108 — Phase 2

Frequently Asked Questions

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

Have previous studies analyzed the efficacy of Autologous Tumor Infiltrating Lymphocytes LN-145?

"Currently, there are 1,647 separate investigations into autologous tumor infiltrating lymphocytes LN-145 being conducted; 246 of these clinical trials have reached phase 3. Primarily concentrated in Philadelphia, Pennsylvania but running globally on 70,461 sites, the scope of this research is truly expansive."

Answered by AI

To what extent has recruitment for this medical experiment been successful?

"Affirmative, the information on clinicaltrials.gov attests that this experiment is actively recruiting subjects. This trial was initially posted in April 2018 and last updated in August of 2022; 95 individuals are being sought from 1 research site."

Answered by AI

Are there specific qualifications that must be met for participation in this medical study?

"This clinical trial seeks 95 volunteers between the ages of 16 and 70, who have giant cell tumor of bone. Moreover, to qualify for inclusion in this study, participants must be 18-70 years old (subjects aged 16-17 may join the osteosarcoma cohort), willing to provide informed consent or parental/legal guardian permission if under 18, have an ECOG performance status 0 or 1; a biopsy site that can produce TIL separate from target lesions amenable to response assessment; discontinued any prior targeted therapies 28 days before enrollment; ANC ≥ 1000mm^3 within 7 days pre-enrollment; hemoglobin ≥"

Answered by AI

What maladies has Autologous Tumor Infiltrating Lymphocytes LN-145 been employed to help alleviate?

"Autologous Tumor Infiltrating Lymphocytes LN-145 is a viable treatment for multiple sclerosis and various other diseases like leukemia, myelocytic neoplasms, unresectable melanoma."

Answered by AI

Are there vacancies available for participant involvement in this medical trial?

"Affirmative. The information hosted on clinicaltrials.gov shows that this medical research, which was first announced in April 2018, is still recruiting participants to its single site for the total of 95 patients."

Answered by AI

Is this study open to adults beyond the age of twenty-five?

"This medical study is looking for individuals aged between 16 and 70 years old."

Answered by AI

Has the Food and Drug Administration endorsed Autologous Tumor Infiltrating Lymphocytes LN-145?

"Although Autologous Tumor Infiltrating Lymphocytes LN-145 has yet to be proven efficacious, existing safety data allows our team at Power to rate its safety a 2 on the scale from 1 to 3."

Answered by AI
~1 spots leftby Jun 2024