Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

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Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Mycoses

Mycosis Fungoides

Lymphoma, T-Cell, Cutaneous

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Communicable Diseases

Bacterial Infections

Bacterial Infections and Mycoses

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

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)

Myeloid Therapeutics

Recurrence

Glioma

Glioblastoma

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Standard treatment associated with circulating leucocytes (blood samplings)

Bevacizumab standard of care

Veronique QUILLIEN, MD

Bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), is an antiangiogenic treatment currently proposed to recurrent high grade glioma patients. Unfortunately some patients fail to respond to this treatment and finding biological factors allowing the discrimination between potential responders and non responders would be very helpful. As the immune system plays a key role in angiogenesis induction and maintenance in cancer, it could serve as a surrogate marker of angiogenesis in cancer patients.

The purpose of this study is to determine the influence of bevacizumab treatment on circulating immune cells in high grade glioma patients and to search for a link between the variation of these cells and the response to treatment.

The following leucocyte subsets will be analyzed in whole blood before treatment and before cycles 3, 5 and 7:

* Classical, intermediate, nonclassical and Tie2 expressing monocytes.
* Regulatory T cells (Treg).
* Myeloid Derived Suppressor cells (MDSCs) The variation of the absolute numbers (or relative percentages) of the cells in the blood of patients will be correlated to the response to treatment assessed according to the RANO criteria.

Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients

Analysis of Different Circulating Immune Cells in Patients With Recurrent Glioblastoma or Mixed Anaplasic Glioma Treated With Bevacizumab and Search for a Link With Response to Treatment

Analysis of blood cells populations variation during treatment with bevacizumab. Last sampling planned before the 7th cycle of bevacizumab.

Relationship between variation of blood cells and RMI response after 6 weeks of treatment

Link between variation of analyzed cellular population and survival.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients	NCT01836536	Glioblastoma Glioma	Bevacizumab sta...	18 Years -	Center Eugene Marquis
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
Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients	NCT01836536	Glioblastoma Glioma	Bevacizumab sta...	18 Years -	Center Eugene Marquis

Spots Global Cancer Trial Database for myeloid cells