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CAR T-cell Therapy

TIL Therapy for Cervical Cancer

Phase 2
Recruiting
Research Sponsored by Iovance Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A bevacizumab and chemotherapy combination is encouraged as a prior line of treatment.
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that uses a patient's own immune cells to fight their cancer.

Who is the study for?
Adults over 18 with recurrent, metastatic, or persistent cervical cancer not treatable by surgery/radiation. Must have measurable lesions and be in good physical condition (ECOG 0-1). Previous systemic therapy is required; however, no more than three lines of chemotherapy for Cohorts 1 and 2. Participants must have adequate organ function, no active infections or HIV, and agree to contraception.Check my eligibility
What is being tested?
The trial studies LN-145 alone or combined with pembrolizumab in treating cervical carcinoma. It's a prospective study where patients receive TIL infusion after lymphodepletion. The goal is to evaluate the effectiveness of this adoptive cell therapy for those who've had previous treatments but still show disease progression.See study design
What are the potential side effects?
Potential side effects include reactions related to immune response due to TIL infusion such as inflammation in various organs, fatigue, blood disorders, infection risk increase from IL-2 treatment post-infusion and possible adverse reactions from pembrolizumab if used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have received bevacizumab and chemotherapy together before.
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I have a tumor that can be surgically removed and is at least 1.5 cm wide.
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My previous treatments with chemotherapy or chemoradiation for cancer were not part of my ongoing systemic therapy.
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My cervical cancer cannot be cured with surgery or radiation.
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My cervical cancer has worsened after 1-3 chemotherapy treatments.
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I have received chemotherapy for recurrent or advanced cervical cancer.
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I stopped all cancer treatments 28 days before my tumor surgery.
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I am fully active or can carry out light work.
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I don't have any ongoing infections and I am HIV negative.
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My cancer has grown after my last treatment, confirmed by scans.
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My organs are functioning well.
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I have been treated with drugs like PD-1 or PD-L1 for my recurring or spreading cancer.
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I've only had chemoradiation or surgery for my cancer, no other treatments.
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I am 18 years or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort 3: Adverse Events
Cohort 4: Efficacy and Adverse Events
Cohort 5: Efficacy and Adverse Events
Secondary outcome measures
Cohort 1 and 2: Adverse Events
Cohort 1 and 2: Disease Control Rate
Cohort 1 and 2: Duration of Response
+8 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort 5 Retreatment CohortExperimental Treatment1 Intervention
Patients who have been previously treated with LN-145 may be given a second treatment with TIL.
Group II: Cohort 4 - Non-enrolling CohortExperimental Treatment1 Intervention
Cohort includes patient population not meeting inclusion criteria in cohort 1 and 2. Post-NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
Group III: Cohort 3 - Combination Arm (TIL + Pembrolizumab) - US OnlyExperimental Treatment1 Intervention
Patients will be administered with pembrolizumab, followed by NMA lymphodepletion, then infused with their autologous TIL (LN-145) followed by pembrolizumab every 3 or 6 weeks post IL-2 administration up to 24 months.
Group IV: Cohort 2 LN-145 monotherapyExperimental Treatment1 Intervention
Patients previously treated with an antiprogrammed cell death protein-1 (PD-1) or anti-programmed death-ligand 1 (PD-L1) checkpoint inhibitor: Post-NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
Group V: Cohort 1 LN-145 monotherapyExperimental Treatment1 Intervention
Post-NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LN-145
2017
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Iovance Biotherapeutics, Inc.Lead Sponsor
20 Previous Clinical Trials
1,507 Total Patients Enrolled
Iovance Medical MonitorStudy DirectorIovance Biotherapeutics, Inc.
1 Previous Clinical Trials

Media Library

LN-145 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03108495 — Phase 2
Cervical Cancer Research Study Groups: Cohort 1 LN-145 monotherapy, Cohort 5 Retreatment Cohort, Cohort 2 LN-145 monotherapy, Cohort 3 - Combination Arm (TIL + Pembrolizumab) - US Only, Cohort 4 - Non-enrolling Cohort
Cervical Cancer Clinical Trial 2023: LN-145 Highlights & Side Effects. Trial Name: NCT03108495 — Phase 2
LN-145 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03108495 — Phase 2

Frequently Asked Questions

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

What medical conditions does LN-145 typically address?

"LN-145 is an effective treatment option for malignant neoplasms, microsatellite instability high, and unresectable melanoma."

Answered by AI

What potential risks could be associated with administering LN-145 to patients?

"With prior data backing its safety, but limited evidence for efficacy, LN-145 was assigned a score of 2 out of 3."

Answered by AI

Is this research effort currently enrolling volunteers?

"Affirmative. The clinicaltrials.gov website attests that this medical experiment, first posted on June 22nd 2017, is presently looking for participants. Approximately 189 people need to be recruited from 19 different sites."

Answered by AI

Are there various sites in the city that are conducting this experiment?

"Eligible patients may be recruited to this clinical trial in three major sites, including University of Southern California Los Angeles (California), University of Chicago (Illinois) and University of California San Diego (Florida). Additionally, there are 19 other recruitment centres."

Answered by AI

What is the aim of this investigation?

"This clinical trial's primary goal is to gauge the efficacy and adverse events of LN-145 over a 60 month period. Secondary objectives include measuring disease control rate, overall survival, and side effects in patients with recurrent, metastatic or persistent cervical carcinoma as per RECIST v1.1 guidelines."

Answered by AI

What is the sample size of this research experiment?

"Iovance Biotherapeutics, Inc. has set a target of 189 participants for this trial; these individuals must meet the defined inclusion criteria in order to be eligible. This clinical study will take place at University of Southern California and University of Chicago, amongst other medical facilities."

Answered by AI

Have any preceding investigations explored the use of LN-145?

"LN-145 was initially analyzed in 2010 at the City of Hope. Presently, there are 250 studies that have been completed as well as 961 active trials taking place largely within Los Angeles County."

Answered by AI
~37 spots leftby Dec 2025