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MT-101 preceded by conditioning (lymphodepleting) chemotherapy

MT-101

IV administration of fludarabine and cyclophosphamide

MT-101 + Conditioning (Lymphodepleting) Chemotherapy

Michele Gerber, MD, MPH

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.

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

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

DOR is the time interval between the date of first assessment of PR or CR to the date of the follow-on first documentation of progressive disease or death, whichever occurs earlier.

PFS is defined as the time from the date of the first administration of MT-101 to the date of first documentation of progressive disease or death, whichever occurs earlier.

OS is defined as the time from date of the first administration of MT-101 to the date of death.

Safety and tolerability of the drug will be determined based on observed adverse events (AEs), including all potential dose limiting toxicities.

The ORR is defined as the number (%) of subjects achieving a best overall response of complete response (CR) or partial response (PR)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of MT-101 in Subjects With CD5+ Relapsed/Refractory TCL	NCT05138458	Lymphoma, T-Cel... Lymphoma, T-Cel... Mycosis Fungoid... Adoptive Cellul... Cell Therapy	MT-101 MT-101 + Condit...	18 Years -	Myeloid Therapeutics
A Study of MT-101 in Subjects With CD5+ Relapsed/Refractory TCL	NCT05138458	Lymphoma, T-Cel... Lymphoma, T-Cel... Mycosis Fungoid... Adoptive Cellul... Cell Therapy	MT-101 MT-101 + Condit...	18 Years -	Myeloid Therapeutics

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