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

Last updated: November 9, 2023
Sponsor: Myeloid Therapeutics
Overall Status: Suspended

Phase

1/2

Condition

Lymphoma

Non-hodgkin's Lymphoma

Mycosis Fungoides

Treatment

MT-101 + Conditioning (Lymphodepleting) Chemotherapy

MT-101

Clinical Study ID

NCT05138458
MTX-TCL-101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Tcell Lymphoma not otherwise specified (PTCL-NOS) , Angioimmunoblastic T cell Lymphoma (AITL), ALK-negative anaplastic large cell lymphoma (ALCL), ALK-positive ALCL, orMycosis Fungoides (MF) stage IIB-IV including large cell transformation
  • CD5-expressing tumor by IHC or flow cytometry of tumor biopsy within 3 months ofScreening or at Screening
  • Eastern Cooperative Oncology Group performance status < 2
  • Adequate organ function as defined in the protocol.

Exclusion

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 completeremission
  • 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 subjectunsuitable for the study or unable to comply with the study requirements.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: MT-101 + Conditioning (Lymphodepleting) Chemotherapy
Phase: 1/2
Study Start date:
December 15, 2021
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010
    United States

    Site Not Available

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Site Not Available

  • Miami Cancer Institute at Baptist Health

    Miami, Florida 33176
    United States

    Site Not Available

  • Dana-Farber/Mass General Brigham Cancer Care

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Tennessee Oncology / Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia 22908
    United States

    Site Not Available

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