Triple negative breast cancer. Malignant neoplasm of breast
Conditions
Interventions
Intervention group: In this study, 10 patients with triple-negative breast cancer who have relapsed following standard initial treatment are included. A fresh biopsy sample is prepared from the patien
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohamad Ahmadvand
Tehran University of Medical Sciences
Outcome results
None listed