Tumor-infiltrating Lymphocytes therapy in Breast Cancer

Phase 1

Conditions: Triple negative breast cancer.
Malignant neoplasm of breast
ICD-50

Registration Number: IRCT20140818018842N34

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Female

Target Recruitment: 10

Inclusion Criteria

Ability to understand the requirements of the study. Specifically, the patient has to provide written informed consent
All patients must have triple-negative breast cancer as defined by the 2018 ASCO guidelines.
Patients must have at least one resectable lesion of a minimum of 1.5 cm in diameter post-resection for TILs investigational production.
Patients must be = 18 years of age at the time of consent.
The patients of childbearing potential must be willing to practice an approved method of birth control during treatment and 12 months after receiving all protocol-related therapy.
Patients must have adequate bone marrow function
Patients must have adequate organ function:
Patients must be seronegative for the human immunodeficiency virus (HIV1 and HIV2).
Patients must have recovered from all prior anticancer treatment-related adverse events.
Patients must have provided written authorization to use and disclose protected health information.
Patients must be able and willing to comply with the study visit schedule and protocol requirements, including long-term follow-up (LTFU).

Exclusion Criteria

Participation in other clinical trials
Patients who have received a vaccine over the past 6 months.
Patients with immune deficiencies
Patients undergoing systemic steroidal treated
Patients who have a history of any cell therapy in the last six months
Patients with a severe active infection

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of Patients With Grades 3-5 of TILs infusion-related Adverse Events (Version 4.03). Timepoint: Daily during the seven days after the injection. Method of measurement: Physical exam, history and lab tests.;Objective Response Rate using the Response Evaluation Criteria in Solid Tumors (RECIST). Timepoint: Before intervention and 1, 3 months after the intervention. Method of measurement: Assessment of tumor size by computed tomography (CT) or magnetic resonance imaging (MRI).

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR). Timepoint: Every 3 months till one year. Method of measurement: Assessment of tumor size by computed tomography (CT) or magnetic resonance imaging (MRI).