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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

Study Summary

This trial will study whether a cancer immunotherapy called TIL therapy is safe and effective in treating patients with metastatic triple-negative breast cancer who have progressed on one to three prior cancer therapies.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR)

Safety Profile

Secondary outcome measures

Complete Response (CR)

Disease Control Rate (DCR)

Duration of Response (DOR)

+2 more

Side effects data

From 2023 Phase 2 trial • 6 Patients • NCT04111510

83%

Fever

83%

Constipation

83%

Nausea

67%

Diarrhea

67%

Anemia

67%

Dyspnea

67%

White blood cell count decreased

67%

Lymphopenia

67%

Thrombocytopenia

67%

Rigors

67%

Headache

67%

Vomiting

67%

Neutropenia

50%

Hypocalcemia

50%

Hyponatremia

50%

Fatigue

50%

Aspartate aminotransferase increased

33%

Cough

33%

Blood bilirubin increased

33%

Pain

33%

Intermittent Emesis

33%

Rash maculo-papular

33%

Anxiety

33%

Febrile neutropenia

33%

Alkaline phosphatase increased

33%

Chills

33%

Infection

17%

Eosinophilia

17%

CPK increased

17%

Hypophosphatemia

17%

Dizziness

17%

Anorexia

17%

Alanine aminotransferase increased

17%

Creatinine increased

17%

Pain in extremity

17%

Sinus tachycardia

17%

Acute kidney injury

17%

Pulmonary edema

17%

Pleural effusion

17%

General edema

17%

Confusion

17%

Bradycardia

17%

Hypertension

17%

Hypoxia

17%

Serum amylase increased

17%

Lipase increased

17%

Hypoalbuminemia

17%

Eye pain

17%

Weight Gain

17%

Hair loss

17%

Platelet count decreased

17%

Nasal congestion

17%

Hypercalcemia

17%

Dehydration

17%

Hyperuricemia

17%

Hypomagnesemia

17%

Loss of appetite

17%

Neutrophil count decreased

17%

Hypokalemia

17%

Hand tremor

100%

80%

60%

40%

20%

Study treatment Arm

LN-145

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

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,737,662 Total Patients Enrolled

27 Trials studying Breast Cancer

3,235 Patients Enrolled for Breast Cancer

Iovance Biotherapeutics, Inc.Industry Sponsor

20 Previous Clinical Trials

1,690 Total Patients Enrolled

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.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants welcome to join this experiment?

"Affirmative. Based on the information available at clinicaltrials.gov, this study is actively searching for 10 new participants to be recruited from 2 sites. The initial posting was made on December 23rd 2019 and the listing has been recently updated on September 7th 2022."

Answered by AI

Is the drug LN-145, derived from Tumor infiltrating lymphocytes (TIL), approved by the Food and Drug Administration?

"While the efficacy of TIL LN-145 has yet to be determined, it is still considered relatively safe and earned a rating of 2 on our safety assessment scale."

Answered by AI

What objectives have been identified to be achieved by this trial?

"This experiment, which is expected to last approximately three years, will assess the safety of LN-145 as a single therapy in metastatic triple negative breast cancer patients. As secondary outcomes, investigators will evaluate complete response (CR), duration of response (DOR) and progression-free survival (PFS) using RECIST 1.1 criteria."

Answered by AI

What is the total headcount of participants in this research project?

"Affirmative, there is information on clinicaltrials.gov demonstrating that this particular trial has an open call for participants. It was first published on December 23rd 2019 and amended most recently on September 7th 2022. The trial requires 10 individuals to be recruited at two medical centres."

Answered by AI