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

Mycosis Fungoides Clinical Trial

— IMAGINE  

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05138458
• Other study ID #: MTX-TCL-101
• Status: Suspended
• Phase: Phase 1/Phase 2
• Start date: December 15, 2021
• Est. completion date: October 2025

Study information

• Verified date: November 2023
• Source: Myeloid Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: October 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Adults age > or equal to18 at the time the Informed Consent is signed

• Refractory or relapsed pathologically confirmed T Cell Lymphoma (TCL): Peripheral T cell Lymphoma not otherwise specified (PTCL-NOS) , Angioimmunoblastic T cell Lymphoma (AITL), ALK-negative anaplastic large cell lymphoma (ALCL), ALK-positive ALCL, or Mycosis Fungoides (MF) stage IIB-IV including large cell transformation

• CD5-expressing tumor by IHC or flow cytometry of tumor biopsy within 3 months of Screening or at Screening

• Eastern Cooperative Oncology Group performance status < 2

• Adequate organ function as defined in the protocol.

Key Exclusion Criteria:

• B1 and B2 disease (as defined in protocol for subjects with MF)

• Known central nervous system involvement by PTCL

• History of allogeneic transplant

• History of intolerance to leukapheresis, plasmapheresis, or blood donation

• Pregnant or nursing women

• Any acute illness including fever (> 100.4°F or > 38°C), except fever related to tumor

• Active systemic bacterial, fungal, or viral infection

• Active chronic infection

• Other primary malignancies, except adequately treated malignancies or complete remission

• Active autoimmune disease that has required systemic therapy in the last 2 years

• History of hemophagocytic lymphohistiocytosis

• History of severe, immediate hypersensitivity reaction attributed to penicillin

• Any other condition that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the study requirements.

Related Conditions & MeSH terms

• Adoptive Cellular Immunotherapy
• Cell Therapy
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Lymphoma, T-Cell, Peripheral
• Mycoses
• Mycosis Fungoides

Intervention

Biological:
• MT-101
CD5 ATAK cells

Other:
• MT-101 + Conditioning (Lymphodepleting) Chemotherapy
IV administration of fludarabine and cyclophosphamide

Locations

Country	Name	City	State
United States	Dana-Farber/Mass General Brigham Cancer Care	Boston	Massachusetts
United States	University of Virginia Comprehensive Cancer Center	Charlottesville	Virginia
United States	Colorado Blood Cancer Institute	Denver	Colorado
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Myeloid Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of response (DOR)	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.	48 weeks
Other	Progression free survival (PFS)	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.	48 weeks
Other	Overall survival (OS)	OS is defined as the time from date of the first administration of MT-101 to the date of death.	48 weeks
Primary	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.	4 weeks
Secondary	MT-101 cell kinetics in blood	The quantity of MT-101 RNA in the blood.	4 weeks
Secondary	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)	24 weeks