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

November 9, 2023 updated by: Myeloid Therapeutics

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber/Mass General Brigham Cancer Care
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 and Cohort 3
MT-101
Biological: MT-101
CD5 ATAK cells
Experimental: Cohort 2 and Cohort 4
MT-101 preceded by conditioning (lymphodepleting) chemotherapy
Other: MT-101 + Conditioning (Lymphodepleting) Chemotherapy
IV administration of fludarabine and cyclophosphamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of MT-101
Time Frame: 4 weeks
Safety and tolerability of the drug will be determined based on observed adverse events (AEs), including all potential dose limiting toxicities.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MT-101 cell kinetics in blood
Time Frame: 4 weeks
The quantity of MT-101 RNA in the blood.
4 weeks
The objective response rate
Time Frame: 24 weeks
The ORR is defined as the number (%) of subjects achieving a best overall response of complete response (CR) or partial response (PR)
24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response (DOR)
Time Frame: 48 weeks
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
Progression free survival (PFS)
Time Frame: 48 weeks
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
Overall survival (OS)
Time Frame: 48 weeks
OS is defined as the time from date of the first administration of MT-101 to the date of death.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myeloid Therapeutics

Investigators

  • Study Director: Michele Gerber, MD, MPH, Myeloid Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

November 18, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Actual)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTX-TCL-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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