← Back to Search

CAR T-cell Therapy

LN-145-S1 for Squamous Cell Carcinoma

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is studying how well giving a person's own TIL cells, which have been grown in the laboratory, works in treating patients with head and neck squamous cell cancer that has come back or spread.

Eligible Conditions
  • Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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
Objective Response Rate
Secondary outcome measures
Disease Control Rate
Duration of Response
Progression-Free Survival

Side effects data

From 2022 Phase 2 trial • 64 Patients • NCT03083873
71%
Thrombocytopenia [4]
71%
Chills
59%
Pyrexia
41%
Anaemia
35%
Leukopenia [1]
35%
Hypophosphataemia
35%
Hypotension
29%
Hypoalbuminaemia
29%
Lymphopenia [2]
29%
Hyponatraemia
29%
Neutropenia [3]
29%
Hypocalcaemia
24%
Nausea
24%
Diarrhoea
24%
Febrile neutropenia
24%
Dyspnoea
24%
Hypokalaemia
18%
Hypoxia
18%
Hypertension
18%
Tachycardia
18%
Fatigue
18%
Blood bilirubin increased
12%
Constipation
12%
Stomatitis
12%
Sinus tachycardia
12%
Pain
12%
Hyperglycaemia
12%
Oedema peripheral
12%
Hypomagnesaemia
12%
Alopecia
12%
Arthralgia
12%
Wheezing
12%
Procedural pain
12%
Infusion related reaction
12%
Muscular weakness
12%
Erythema
12%
Rash maculo-papular
12%
Flushing
12%
Productive cough
6%
Respiratory tract haemorrhage
6%
Haematuria
6%
Vomiting
6%
Candida infection
6%
Abnormal dreams
6%
Headache
6%
Gastrooesophageal reflux disease
6%
Post procedural haemorrhage
6%
Rash erythematous
6%
Acute kidney injury
6%
Mass
6%
Activated partial thromboplastin time prolonged
6%
Blood lactate dehydrogenase increased
6%
Oropharyngeal pain
6%
Bronchitis
6%
Skin laceration
6%
Pneumonia aspiration
6%
Gastrostomy tube site complication
6%
Paraesthesia
6%
Restlessness
6%
Petechiae
6%
Aspartate aminotransferase increased
6%
Dermatitis acneiform
6%
Acute respiratory distress syndrome
6%
Bronchitis viral
6%
Decreased appetite
6%
Haemolytic anaemia
6%
Vision blurred
6%
Supraventricular tachycardia
6%
Neutropenia [1]
6%
Dysphagia
6%
Embolism
6%
Rash
6%
Odynophagia
6%
Abdominal distension
6%
Anxiety
6%
Metabolic acidosis
6%
Joint swelling
6%
Cyanosis
6%
Mood altered
6%
Hyperhidrosis
6%
Peripheral swelling
6%
Temperature intolerance
6%
Insomnia
6%
Syncope
6%
Proteinuria
6%
Influenza
6%
Blood alkaline phosphatase increased
6%
Musculoskeletal chest pain
6%
Cough
6%
Back pain
6%
Acidosis
6%
Hypersomnia
6%
Pollakiuria
6%
Increased upper airway secretion
6%
Pulmonary congestion
6%
Skin mass
6%
Thrombophlebitis superficial
6%
Pruritus
6%
Deep vein thrombosis
6%
Bacteraemia
6%
Rhinorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2
Cohort 1
Cohort 3
Cohort 5
Cohort 4

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort 5Experimental Treatment2 Interventions
LN-145 cryopreserved/LN-145-S1 cryopreserved TIL re-treatment
Group II: Cohort 4Experimental Treatment1 Intervention
Treatment with LN-145-S1 cryopreserved TIL
Group III: Cohort 3Experimental Treatment1 Intervention
Treatment with LN-145 Generation 3 (Gen 3), cryopreserved TIL
Group IV: Cohort 2Experimental Treatment1 Intervention
Treatment with LN-145 Generation 2 (Gen 2), cryopreserved TIL
Group V: Cohort 1Experimental Treatment1 Intervention
Treatment with LN-145, Generation 1 (Gen 1), non-cryopreserved TIL
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LN-145-S1
2017
Completed Phase 2
~70
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
1,632 Total Patients Enrolled
Iovance Biotherapeutics Medical MonitorStudy DirectorIovance Biotherapeutics
3 Previous Clinical Trials
426 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of LN-145/LN-145-S1 Autologous Tumor Infiltrating Lymphocytes in the Treatment of Squamous Cell Carcinoma of the Head & Neck
2017. "Study of LN-145/LN-145-S1 Autologous Tumor Infiltrating Lymphocytes in the Treatment of Squamous Cell Carcinoma of the Head & Neck". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03083873.
~8 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top