Personalized cell therapy shows promise for tough cervical cancers

NCT ID NCT03108495

Disease control Sponsor: Iovance Biotherapeutics, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This phase 2 study tested a personalized treatment called LN-145 for women with recurrent or advanced cervical cancer. The therapy uses a patient's own tumor-fighting immune cells, grown in a lab and infused back. The trial aimed to see if it could shrink tumors, but it was terminated early, limiting the data.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: LN-145 (tumor infiltrating lymphocytes, a personalized cell therapy made from the patient's own immune cells)
What this could lead to: If successful, this could point toward a new treatment option for women with advanced cervical cancer that has not responded to standard therapies.
What could go wrong: The trial was terminated early, so results are limited. Cell therapies are complex, expensive, and may cause serious side effects like severe immune reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

210 people

The number who actually took part.

Started

Jun 2017

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: To be eligible for the study, participants must meet ALL of the following criteria prior to participation: 1. Must be ≥ 18 years of age at the time of consent. Enrollment of participants \> 70 years of age may be allowed after consultation with the Medical Monitor. 2. Must have recurrent, metastatic, or persistent squamous cell carcinoma (SCC), adenosquamous carcinoma (ASC), or adenocarcinoma (AC) of the cervix that is not amenable to curative treatment with surgery and/or radiation therapy. 3. At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL; surgical removal with minimal morbidity (defined as any procedure for which expected hospitalization is ≤ 3 days) 4. At least one measurable target lesion, as defined by RECIST v1.1. 5. Cohort 1 and Cohort 2: Progression during or following at least one, but no more than three, prior systemic chemotherapeutic treatments for recurrent, metastatic, or persistent cervical carcinoma * A line of systemic therapy is defined as any chemotherapy or multiple-agent chemotherapy regimen that was administered for recurrent, metastatic, or persistent SCC, ASC, or AC of the cervix. * A bevacizumab and chemotherapy combination is encouraged as a prior line of treatment. * Neither chemoradiation, nor chemotherapy in the neoadjuvant or adjuvant settings are considered as a prior line of systemic therapy. Cohort 2: Must also have previously received treatment with a checkpoint inhibitor (ie, PD-1, PD-L1\]) in the setting of recurrent, metastatic, or persistent disease either as monotherapy or in combination (eg, in combination with chemotherapy or another immune agent) Cohort 3 (United States only): Must have not received any therapies other than prior chemoradiation or surgery for loco-regional disease 6. Any prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted agents, and immunologic agents must be discontinued at least 28 days prior to tumor resection. 7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 8. Must have adequate organ function. 9. Participant has no evidence of any active viral, bacterial, or fungal infection requiring ongoing systemic treatment. Participants must be seronegative for the human immunodeficiency virus (HIV). Participants with acute or chronic hepatitis infections may be enrolled if the viral load by nucleic acid amplification test (NAAT) is undetectable with/without active treatment 10. Participants of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after receiving the last protocol-related therapy. 11. Prior to study Enrollment (tumor resection), participant must have documentation of radiological disease progression after the most recent therapy Exclusion Criteria: Participants who meet any of the following criteria are not eligible for participation in this study: 1. Participants who have received an organ allograft or prior cell transfer therapy except for prior LN-145 therapy in the setting of re-treatment only. 2. Participants who require ongoing systemic steroid therapy (\> 10 mg/day of prednisone or other steroid equivalent dose). 3. Participants who currently have prior therapy-related toxicities Grade \> 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0; except for peripheral neuropathy, alopecia, or vitiligo prior to Enrollment (tumor resection). 4. . Participants who have a history of hypersensitivity to any component or excipient of LN-145 or other study drugs: • NMA-LD preparative regimen (cyclophosphamide, mesna, and fludarabine) 5. Participants who have active systemic infections, coagulation disorders, or other active major medical illness(es) of the cardiovascular, respiratory, or immune system, including evidence in the medical history of urinary tract obstruction, a positive cardiac stress test, myocardial infarction, cardiac arrhythmia, obstructive or restrictive pulmonary disease, or other conditions that in the opinion of the Investigator would increase the risk of participation. 6. Participants with symptomatic and/or untreated brain metastases (of any size and any number) • Participants with definitively treated brain metastases may be considered for Enrollment, and must be stable for ≥ 14 days prior to beginning the NMA-LD preparative regimen 7. Participants who have any form of primary immunodeficiency (such as severe combined immunodeficiency \[SCID\] or acquired immunodeficiency syndrome \[AIDS\]) 8. Participants who have a diagnosis of end-stage renal disorder requiring hemodialysis 9. Participants who have a left ventricular ejection fraction (LVEF) \< 45% or who are New York Heart Association (NYHA) Class 2 or higher. 10. Participants who have a documented forced expiratory volume in 1 second (FEV1) of ≤ 60% 11. Participants who have had another primary malignancy within the previous 3 years (except for curatively treated localized malignancy that has not required treatment for \> 1 year, and in the judgement of the Investigator, does not pose a significant risk of recurrence including, but not limited to, non-melanoma skin cancer or bladder cancer) 12. Participants who are of the following protected classes will be excluded, including: * Pregnant, parturient, or breastfeeding women * Persons who are hospitalized without consent or those deprived of liberty because of a judiciary or administrative decision * Participants with a legal protection measure or a person who cannot express his/her consent * Participants in emergency situations who cannot consent to the study 13. Participants who have received a live or attenuated vaccine within 28 days prior to beginning the NMA-LD preparative regimen 14. Participants whose cancer requires immediate attention or who would otherwise suffer a disadvantage by participating in this study 15. Cohort 1 and Cohort 3: Participants who have received prior treatment with immunotherapy (eg, PD-1, PD-L1, or anti-cytotoxic T lymphocyte-associated antigen-4 \[CTLA-4\] antibodies) 16. Participants who have Grade ≥ 2 hemorrhage within 14 days prior to Enrollment (tumor resection) 17. Cohort 3: Participants may not have active or prior documented autoimmune or inflammatory disorders (including pneumonitis, inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]).

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Conditions

The condition(s) this trial relates to.

cervical carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical carcinoma

Contacts and locations

Locations

Academisch Medisch Centrum

Amsterdam, AZ, 1105, Netherlands
Allegheny Health

Pittsburgh, Pennsylvania, 15224, United States
Augusta University

Augusta, Georgia, 30912-0003, United States
Avera Medical Group Oncology

Sioux Falls, South Dakota, 57105, United States
Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom
Centre Hospitalier Lyon Sud

Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France
Centre Hospitalier Universitaire Vaudois Lausanne - Centre Pluridisciplinaire d'Oncologie

Lausanne, Switzerland
Centre Léon Bérard

Lyon, 69008, France
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain
Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Gustave Roussy Cancer Campus

Villejuif, 94805, France
Guy's & St.Thomas NHS Foundation Trust

London, SE1 9RT, United Kingdom
Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain
Hospital Universitari Vall d'Hebrón

Barcelona, 08035, Spain
Hospital Universitario Madrid Sanchinarro

Madrid, 28050, Spain
Inselspital

Bern, CH-3010, Switzerland
Institut Català d'Oncologia

Barcelona, 08908, Spain
Istituto Europeo di Oncologia

Miano, Milano, 20141, Italy
James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States
Karmanos Cancer Institute

Detroit, Michigan, 48201, United States
LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States
MD Anderson Cancer Center

Houston, Texas, 77030, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53225, United States
NHS Greater Glasgow and Clyde

Glasgow, Scotland, G12 0YN, United Kingdom
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Rutgers University

Newark, New Jersey, 07103, United States
Sarah Cannon Research Institute London

London, England, W1G 6AD, United Kingdom
St. Joseph's Hospital and Medical Center Center For Women's Health

Phoenix, Arizona, 85013, United States
Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States
The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287-0013, United States
UPMC Cancer Center

Pittsburgh, Pennsylvania, 15232, United States
University College London Hospitals NHS Foundation Trust

London, England, W1G 6BW, United Kingdom
University of California San Diego

San Diego, California, 92093, United States
University of Chicago

Chicago, Illinois, 60637, United States
University of Florida Health Cancer Center

Orlando, Florida, 32806, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of South Florida H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States
University of Southern California

Los Angeles, California, 90033, United States
University of Virginia

Charlottesville, Virginia, 22908, United States
Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, 01307, Germany
Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

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