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CAR T-cell Therapy

TIL Therapy for Cervical Cancer

Phase 2
Waitlist Available
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
No Placebo-Only Group
All Individual Drugs Already Approved

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.
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.
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 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 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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My cancer has grown after my last treatment, confirmed by scans.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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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.
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I don't have severe side effects from previous treatments, except for nerve issues, hair loss, or skin color changes.
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I am under legal protection or unable to give consent myself.
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I am unable to give consent due to an emergency situation.
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I have had immunotherapy for my condition before.
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I do not have any autoimmune or inflammatory disorders.
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I am on hemodialysis for end-stage kidney disease.
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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.
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I have brain metastases that are either causing symptoms or have not been treated.

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

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

Side effects data

From 2022 Phase 2 trial • 64 Patients • NCT03083873
75%
Thrombocytopenia [4]
56%
Anaemia
56%
Hypophosphataemia
50%
Hypocalcaemia
44%
Diarrhoea
44%
Chills
44%
Pyrexia
44%
Hypomagnesaemia
44%
Hypotension
38%
Dyspnoea
31%
Leukopenia [1]
31%
Neutropenia [3]
31%
Febrile neutropenia
31%
Hypokalaemia
31%
Cough
25%
Constipation
25%
Dry mouth
25%
Hypoalbuminaemia
19%
Fatigue
19%
Pneumonia
19%
Infusion related reaction
19%
Decreased appetite
19%
Hypoglycaemia
19%
Hyponatraemia
19%
Confusional state
19%
Hypoxia
19%
Hypertension
13%
Oral pain
13%
Lymphopenia [2]
13%
Atrial fibrillation
13%
Sinus tachycardia
13%
Vomiting
13%
Oedema
13%
Capillary leak syndrome
13%
Respiratory failure
13%
Hypercalcaemia
13%
Hypernatraemia
13%
Arthralgia
13%
Back pain
13%
Acute kidney injury
13%
Pollakiuria
13%
Aspiration
13%
Pulmonary oedema
13%
Tachypnoea
13%
Petechiae
13%
Rash
13%
Embolism
6%
Cytokine release syndrome
6%
Mucosal infection
6%
Muscle tightness
6%
Hypersensitivity
6%
Alopecia
6%
Thrombocytosis
6%
Supraventricular tachycardia
6%
Tachycardia
6%
Tachyarrhythmia
6%
Visual impairment
6%
Ventricular tachycardia
6%
Cheilitis
6%
Thrombocytopenia [2]
6%
Dysphagia
6%
Faeces discoloured
6%
Nausea
6%
Mouth haemorrhage
6%
Mouth ulceration
6%
Oral dysaesthesia
6%
Face oedema
6%
Localised oedema
6%
Malaise
6%
Multiple organ dysfunction syndrome
6%
Swelling face
6%
Oedema peripheral
6%
Septic shock
6%
Acute respiratory failure
6%
Scrotal infection
6%
Shock haemorrhagic
6%
Sepsis
6%
Soft tissue injury
6%
Incision site pain
6%
Tracheal haemorrhage
6%
Wound haemorrhage
6%
Alanine aminotransferase increased
6%
Blood alkaline phosphatase increased
6%
Blood bilirubin increased
6%
Blood creatinine increased
6%
Electrocardiogram QT prolonged
6%
International normalised ratio increased
6%
Weight decreased
6%
Urine output decreased
6%
Weight increased
6%
Acidosis
6%
Hyperkalaemia
6%
Hypervolaemia
6%
Hypermagnesaemia
6%
Lactic acidosis
6%
Malnutrition
6%
Metabolic syndrome
6%
Muscular weakness
6%
Dizziness
6%
Disturbance in attention
6%
Headache
6%
Dysgeusia
6%
Encephalopathy
6%
Peripheral sensory neuropathy
6%
Neuropathy peripheral
6%
Somnolence
6%
Anxiety
6%
Delirium
6%
Insomnia
6%
Irritability
6%
Bladder pain
6%
Dysuria
6%
Oliguria
6%
Haematuria
6%
Micturition urgency
6%
Haemoptysis
6%
Dysphonia
6%
Epistaxis
6%
Laryngeal oedema
6%
Pleural effusion
6%
Respiratory distress
6%
Rhinitis allergic
6%
Rhinorrhoea
6%
Decubitus ulcer
6%
Purpura
6%
Rash maculo-papular
6%
Skin ulcer
6%
Deep vein thrombosis
6%
Distributive shock
6%
Flushing
6%
Haematoma
6%
Pallor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 3
Cohort 1
Cohort 2
Cohort 5
Cohort 4

Awards & Highlights

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.

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
23 Previous Clinical Trials
1,646 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
~22 spots leftby Dec 2025
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