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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.
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 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.
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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.

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

Side effects data

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

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

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
~32 spots leftby Dec 2025