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IRCT20140818018842N34 IRCT 2023-04-25 Tehran University of Medical Sciences Tumor-infiltrating Lymphocytes therapy in Breast Cancer Investigating the safety and efficacy of cell therapy with Tumor-Infiltrating Lymphocytes (TILs) in the Triple Negative Breast Cancer 2023-05-10 anticipated 10 Complete https://irct.ir/trial/66505 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1-2 Triple negative breast cancer. 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 patient's tumor tissue and transferred to RPMI 1640 medium with antibiotics for cell processing. The sample is crushed and made into single cells by an enzymatic method (collagenase type 4 enzyme). TIL cells are then cultivated for 14 days in a culture medium containing the anti-CD3 antibody and human IL-2 and irradiated feeder cells under GMP conditions. Patients receive a conditioning lymphodepletion regimen before the TILs. It includes the infusion of 25 mg/mm Fludarabine from seven to four days before the TILs (days -7 to - 4), followed by cyclophosphamide 25mg/kg on days -3 and -2. And then, a total dose of 10 billion (10 thousand million) cells, prepared in the laboratory environment, will be injected on day zero.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mohamad Ahmadvand
North Kargar Ave.
tehran Iran (Islamic Republic of) 1411713135 +98 21 8800 4140 ahmadvand.mohamad64@yahoo.com Tehran University of Medical Sciences scientific Maryam Barkhordar
North Kargar Ave.
tehran Iran (Islamic Republic of) 1411713135 +98 21 8800 4140 barkhordarm.n@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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). 18 years 65 years Female 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 ICD-50 Malignant neoplasm of breast N/A 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 patient's tumor tissue and transferred to RPMI 1640 medium with antibiotics for cell processing. The sample is crushed and made into single cells by an enzymatic method (collagenase type 4 enzyme). TIL cells are then cultivated for 14 days in a culture medium containing the anti-CD3 antibody and human IL-2 and irradiated feeder cells under GMP conditions. Patients receive a conditioning lymphodepletion regimen before the TILs. It includes the infusion of 25 mg/mm Fludarabine from seven to four days before the TILs (days -7 to - 4), followed by cyclophosphamide 25mg/kg on days -3 and -2. And then, a total dose of 10 billion (10 thousand million) cells, prepared in the laboratory environment, will be injected on day zero. 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). 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). Tehran University of Medical Sciences Approved 2023-01-25 Ethic committee of Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran Univer Kargar shomali Ave., Shariati hospital tehran Tehran Iran (Islamic Republic of)