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CAR T-cell Therapy
Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer
Phase 2
Waitlist Available
Led By Michael Hurwitz, MD
Research Sponsored by Yale University
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 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment that uses a patient's own immune cells to fight metastatic Triple Negative Breast Cancer. It targets patients who have not responded well to previous treatments. The therapy aims to boost the body's natural defenses against cancer.
Eligible Conditions
- Metastatic Breast Cancer, Triple Negative Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate (ORR)
Safety Profile
Secondary study objectives
Complete Response (CR)
Disease Control Rate (DCR)
Duration of Response (DOR) in Days
+2 moreSide effects data
From 2023 Phase 2 trial • 6 Patients • NCT0411151083%
Fever
83%
Constipation
83%
Nausea
67%
Headache
67%
Anemia
67%
Lymphopenia
67%
White blood cell count decreased
67%
Neutropenia
67%
Vomiting
67%
Dyspnea
67%
Rigors
67%
Diarrhea
67%
Thrombocytopenia
50%
Hyponatremia
50%
Fatigue
50%
Aspartate aminotransferase increased
50%
Hypocalcemia
33%
Chills
33%
Febrile neutropenia
33%
Intermittent Emesis
33%
Infection
33%
Pain
33%
Anxiety
33%
Cough
33%
Alkaline phosphatase increased
33%
Blood bilirubin increased
33%
Rash maculo-papular
17%
Eosinophilia
17%
Platelet count decreased
17%
Neutrophil count decreased
17%
Hyperuricemia
17%
Hypoalbuminemia
17%
Hypophosphatemia
17%
Hypomagnesemia
17%
Confusion
17%
Hypoxia
17%
Anorexia
17%
Creatinine increased
17%
Alanine aminotransferase increased
17%
Pleural effusion
17%
Nasal congestion
17%
Loss of appetite
17%
Pulmonary edema
17%
CPK increased
17%
Dehydration
17%
Hair loss
17%
Lipase increased
17%
Serum amylase increased
17%
Hypokalemia
17%
Dizziness
17%
Eye pain
17%
Pain in extremity
17%
Weight Gain
17%
Hypertension
17%
Sinus tachycardia
17%
Bradycardia
17%
Hypercalcemia
17%
Hand tremor
17%
General edema
17%
Acute kidney injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
LN-145
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: LN-145Experimental Treatment1 Intervention
LN-145 will be delivered as a single therapy in patients with Metastatic Triple Negative Breast Cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tumor infiltrating lymphocytes (TIL) LN-145
2019
Completed Phase 2
~10
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,468 Total Patients Enrolled
26 Trials studying Breast Cancer
3,027 Patients Enrolled for Breast Cancer
Iovance Biotherapeutics, Inc.Industry Sponsor
25 Previous Clinical Trials
1,866 Total Patients Enrolled
1 Trials studying Breast Cancer
30 Patients Enrolled for Breast Cancer
Michael Hurwitz, MD5.01 ReviewsPrincipal Investigator - Yale University
Yale University
5Patient Review
Dr. Hurwitz is an outstanding oncologist who is both intelligent and compassionate. He communicates with his patients plainly and honestly, without rushing them. He also has a great sense of humor and is professional but warm.