Actively Recruiting
Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors
Led by Iovance Biotherapeutics, Inc. · Updated on 2025-06-19
245
Participants Needed
45
Research Sites
535 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL \[LN-144/LN-145 (lifileucel)\] in combination with immune checkpoint inhibitors or TIL \[LN-144/LN-145 (lifileucel) and LN-145-S1\] as a single agent therapy.
CONDITIONS
Official Title
Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of unresectable or metastatic melanoma Stage IIIC to IV, advanced/recurrent/metastatic head and neck squamous cell carcinoma, or Stage III/IV non-small cell lung cancer
- For some cohorts, prior treatment with up to 3 or 4 systemic therapies depending on cohort; must show disease progression after last therapy
- Patients in certain cohorts must have received prior PD-1 or immune checkpoint inhibitor therapy as specified
- Must have at least one tumor lesion that can be surgically removed
- Must have measurable disease remaining after tumor removal
- Must be 18 years or older (some cohorts accept age 12 and above)
- ECOG performance status of 0 or 1, with life expectancy of at least 6 months
- Willingness to use approved birth control methods during and after treatment as specified
You will not qualify if you...
- Melanoma of uveal or ocular origin
- History of allogeneic organ transplant or cell therapy with conditioning chemotherapy in past 20 years
- Symptomatic untreated brain metastases or leptomeningeal metastases history
- Use of systemic steroids above 10 mg prednisone equivalent daily (except replacement therapy at 10 mg or less)
- Pregnant or breastfeeding
- Active medical illnesses posing increased risk for participation
- History of autoimmune disorders requiring treatment in specified cohorts
- Live or attenuated vaccine within 28 days before treatment
- Any form of primary immunodeficiency
- Hypersensitivity to study drug components
- Left ventricular ejection fraction below 45% or significant heart conditions
- Respiratory dysfunction or smoking history not meeting specified lung function measures
- Other primary malignancy within past 3 years
- Participation in other interventional clinical studies within 21 days before treatment
- Prior immune checkpoint inhibitor-related adverse events requiring steroids or discontinuation in specified cohorts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 45 locations
1
University of California, San Diego
La Jolla, California, United States, 92093
Terminated
2
University of Southern California
Los Angeles, California, United States, 90007
Active, Not Recruiting
3
University of California, Los Angeles
Los Angeles, California, United States, 90095
Active, Not Recruiting
4
University of Colorado
Denver, Colorado, United States, 80045
Active, Not Recruiting
5
Yale University
New Haven, Connecticut, United States, 06520
Active, Not Recruiting
6
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Active, Not Recruiting
7
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Withdrawn
8
Orlando Health Cancer Institute
Orlando, Florida, United States, 32610
Actively Recruiting
9
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Active, Not Recruiting
10
University of Louisville
Louisville, Kentucky, United States, 40292
Actively Recruiting
11
University of Maryland
Baltimore, Maryland, United States, 21201
Active, Not Recruiting
12
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
13
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Active, Not Recruiting
14
Henry Ford Health System
Detroit, Michigan, United States, 48202
Active, Not Recruiting
15
MD Anderson at Cooper
Camden, New Jersey, United States, 08103
Actively Recruiting
16
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
17
Columbia University
New York, New York, United States, 10027
Withdrawn
18
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Active, Not Recruiting
19
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Terminated
20
Ohio State University
Columbus, Ohio, United States, 43201
Actively Recruiting
21
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Withdrawn
22
Huntsman Cancer Hospital
Salt Lake City, Utah, United States, 84112
Withdrawn
23
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Actively Recruiting
24
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Terminated
25
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C1
Active, Not Recruiting
26
Centre Léon Berard
Lyon, France, 69008
Withdrawn
27
Klinikum rechts der Isar der Technischen Universität München
München, Bavaria, Germany, 81675
Withdrawn
28
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, Germany, 01307
Withdrawn
29
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Schleswig-Holstein, Germany, 23538
Actively Recruiting
30
Laiko General Hospital of Athens
Athens, Attica, Greece, 11527
Actively Recruiting
31
Attikon University General Hospital
Athens, Attica, Greece, 12461
Active, Not Recruiting
32
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
33
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Málaga, Spain, 29016
Terminated
34
University Hospital Vall d'Hebron
Barcelona, Spain, 08035
Withdrawn
35
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, Spain, 08908
Actively Recruiting
36
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Withdrawn
37
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
38
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
39
Hospital Universitario HM Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
40
Universitätsspital Basel
Basel, Switzerland, 4031
Withdrawn
41
Universitaetsspital Bern
Bern, Switzerland, 3010
Active, Not Recruiting
42
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Terminated
43
Guy's Hospital
London, England, United Kingdom, SE19RT
Actively Recruiting
44
The Royal Marsden NHS Foundation Trust
London, England, United Kingdom, SW3 6JJ
Actively Recruiting
45
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Withdrawn
Research Team
I
Iovance Biotherapeutics Study Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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