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CAR T-cell Therapy

Tumor infiltrating lymphocytes (TIL) LN-145 for 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

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 more

Side effects data

From 2023 Phase 2 trial • 6 Patients • NCT04111510

83%

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%

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

Do I qualify?Apply below to find out

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,925 Previous Clinical Trials

3,031,775 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.