This is a Phase 1/2 study to test the safety, tolerability, and efficacy of the investigational agent MT-101 in patients with T cell Lymphoma. MT-101 is made with myeloid cells collected from the patient's blood. The myeloid cells are modified and later infused back into their veins. The modified myeloid cells recognize the tumor cells and are designed to target and kill them.
The research study is divided into two parts. The first part will be to determine the safety and tolerability of the study drug product. During this part of the study, there will be 4 groups of study patients. The first group of patients will receive a low dose of cells, the second group will receive the low dose of cells and lymphodepleting chemotherapy to reduce the number of T cells in the blood, the third group will receive a higher dose of cells, and the fourth group will receive the higher dose of cells and lymphodepleting chemotherapy to reduce the number of T cells in the blood. In the second part of the study, cells with or without chemotherapy will be administered based on results of Part 1 and the safety, tolerability, and efficacy of MT-101 will be assessed. All patient groups will receive 6 doses of drug product over 3 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
CD5 ATAK cells
IV administration of fludarabine and cyclophosphamide
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Dana-Farber/Mass General Brigham Cancer Care
Boston, Massachusetts, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Safety and Tolerability of MT-101
Safety and tolerability of the drug will be determined based on observed adverse events (AEs), including all potential dose limiting toxicities.
Time frame: 4 weeks
MT-101 cell kinetics in blood
The quantity of MT-101 RNA in the blood.
Time frame: 4 weeks
The objective response rate
The ORR is defined as the number (%) of subjects achieving a best overall response of complete response (CR) or partial response (PR)
Time frame: 24 weeks
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States