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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
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)
Neither chemoradiation, nor chemotherapy in the neoadjuvant or adjuvant settings are considered as a prior line of systemic therapy.
Must not have
NMA-LD preparative regimen (cyclophosphamide, mesna, and fludarabine)
Patients who have a left ventricular ejection fraction (LVEF) < 45% or who are New York Heart Association (NYHA) Class 2 or higher.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights
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 belowSelect...
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.
Select...
My cervical cancer cannot be cured with surgery or radiation.
Select...
My cervical cancer has worsened after 1-3 chemotherapy treatments.
Select...
I stopped all cancer treatments 28 days before my tumor surgery.
Select...
I am fully active or can carry out light work.
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My cancer has grown after my last treatment, confirmed by scans.
Select...
I have been treated with drugs like PD-1 or PD-L1 for my recurring or spreading cancer.
Select...
I've only had chemoradiation or surgery for my cancer, no other treatments.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am receiving a specific chemotherapy regimen before my transplant.
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My heart's pumping ability is below normal, or I have moderate to severe heart problems.
Select...
I don't have severe side effects from previous treatments, except for nerve issues, hair loss, or skin color changes.
Select...
I am under legal protection or unable to give consent myself.
Select...
I am unable to give consent due to an emergency situation.
Select...
I have had immunotherapy for my condition before.
Select...
I do not have any autoimmune or inflammatory disorders.
Select...
I am on hemodialysis for end-stage kidney disease.
Select...
I have not had significant bleeding in the last 2 weeks.
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I need more than 10 mg/day of prednisone or an equivalent steroid.
Select...
I have brain metastases that are either causing symptoms or have not been treated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
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 moreSide effects data
From 2022 Phase 2 trial • 64 Patients • NCT0308387375%
Chills
63%
Hypotension
63%
Pyrexia
63%
Hyponatraemia
50%
Anaemia
50%
Thrombocytopenia [4]
50%
Hypophosphataemia
50%
Lymphopenia [2]
38%
Leukopenia [1]
38%
Fatigue
38%
Vomiting
38%
Neutropenia [3]
38%
Hypokalaemia
25%
Mucosal infection
25%
Hypocalcaemia
25%
Dyspnoea
25%
Pneumonia
25%
Cough
25%
Sinus tachycardia
25%
Diarrhoea
25%
Febrile neutropenia
25%
Aspartate aminotransferase increased
25%
Tachycardia
13%
Myocardial infarction
13%
Eye haemorrhage
13%
Anxiety
13%
Hypoxia
13%
Blood alkaline phosphatase decreased
13%
Weight increased
13%
Depression
13%
Urinary incontinence
13%
Dysgeusia
13%
Dry mouth
13%
Infusion related reaction
13%
Nasal congestion
13%
Erythema
13%
Urine flow decreased
13%
Pulmonary oedema
13%
Headache
13%
Dysphagia
13%
Pneumonia aspiration
13%
Dehydration
13%
Basophilia
13%
Hypochloraemia
13%
Somnolence
13%
Thrombocytosis
13%
Localised oedema
13%
Constipation
13%
Blood bilirubin increased
13%
Pleural effusion
13%
Biliary obstruction
13%
Blood culture positive
13%
Troponin increased
13%
Pruritus
13%
Aspiration
13%
Neutrophilia
13%
Nausea
13%
Weight decreased
13%
Hypomagnesaemia
13%
Contusion
13%
Insomnia
13%
Nasal dryness
13%
Alanine aminotransferase increased
13%
Tremor
13%
Muscular weakness
13%
Hypercalcaemia
13%
Device related infection
13%
Monocytosis
13%
Influenza like illness
13%
Rash
13%
Blood creatine phosphokinase increased
13%
Hypertension
13%
Alopecia
13%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1
Cohort 5
Cohort 2
Cohort 4
Cohort 3
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
1,506 Total Patients Enrolled
Iovance Medical MonitorStudy DirectorIovance Biotherapeutics, Inc.
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am receiving a specific chemotherapy regimen before my transplant.You have a condition that weakens your immune system, like severe combined immunodeficiency (SCID) or acquired immunodeficiency syndrome (AIDS).My heart's pumping ability is below normal, or I have moderate to severe heart problems.I have received bevacizumab and chemotherapy together before.I don't have severe side effects from previous treatments, except for nerve issues, hair loss, or skin color changes.I have not had an organ transplant or cell therapy, except for LN-145.I am under legal protection or unable to give consent myself.I have a tumor that can be surgically removed and is at least 1.5 cm wide.I do not have serious infections, bleeding disorders, or major heart, lung, or immune system illnesses.My previous treatments with chemotherapy or chemoradiation for cancer were not part of my ongoing systemic therapy.I haven't had any other cancers in the last 3 years, except for non-threatening skin or bladder cancer.I am unable to give consent due to an emergency situation.I have had immunotherapy for my condition before.I do not have any autoimmune or inflammatory disorders.I am fully active or can carry out light work.My cervical cancer has worsened after 1-3 chemotherapy treatments.My cervical cancer cannot be cured with surgery or radiation.I have received chemotherapy for recurrent or advanced cervical cancer.I stopped all cancer treatments 28 days before my tumor surgery.I don't have any ongoing infections and I am HIV negative.My cancer has grown after my last treatment, confirmed by scans.You have had a bad reaction or allergy to any part of the study drug LN-145 or other medications being used in the study.I am on hemodialysis for end-stage kidney disease.I have not had significant bleeding in the last 2 weeks.My organs are functioning well.I have been treated with drugs like PD-1 or PD-L1 for my recurring or spreading cancer.I've only had chemoradiation or surgery for my cancer, no other treatments.My brain metastases have been treated and stable for at least 14 days.I am 18 years or older.I need more than 10 mg/day of prednisone or an equivalent steroid.I have not received a live vaccine in the last 28 days.I have brain metastases that are either causing symptoms or have not been treated.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 LN-145 monotherapy
- Group 2: Cohort 5 Retreatment Cohort
- Group 3: Cohort 2 LN-145 monotherapy
- Group 4: Cohort 3 - Combination Arm (TIL + Pembrolizumab) - US Only
- Group 5: Cohort 4 - Non-enrolling Cohort
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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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