Spots Global Cancer Trial Database for A Study of MT-101 in Subjects With CD5+ Relapsed/Refractory TCL

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Trial Identification

Brief Title: A Study of MT-101 in Subjects With CD5+ Relapsed/Refractory TCL

Official Title: A Phase 1/2, Open-Label, First-in-human, Multiple Ascending Dose Multicenter Study of MT-101 in Subjects With CD5+ Relapsed/Refractory T Cell Lymphoma

Study ID: NCT05138458

Conditions

Lymphoma, T-Cell, Peripheral

Lymphoma, T-Cell, Cutaneous

Mycosis Fungoides

Adoptive Cellular Immunotherapy

Cell Therapy

Interventions

MT-101

MT-101 + Conditioning (Lymphodepleting) Chemotherapy

Study Description

Brief Summary: 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.

Detailed Description: 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.