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

Primary Purpose

Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MT-101
MT-101 + Conditioning (Lymphodepleting) Chemotherapy
Sponsored by
Myeloid Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, T-Cell, Peripheral focused on measuring T Cell Lymphoma, PTCL, CTCL, MF, MT-101, CD5 chimeric antigen receptor, Myeloid cells, Monocytes, Chimeric Antigen Receptor, CAR Monocyte Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • City of Hope Comprehensive Cancer CenterRecruiting
  • Colorado Blood Cancer InstituteRecruiting
  • Miami Cancer Institute at Baptist HealthRecruiting
  • Dana-Farber/Mass General Brigham Cancer CareRecruiting
  • University of Nebraska Medical CenterRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Thomas Jefferson UniversityRecruiting
  • Tennessee Oncology / Sarah Cannon Research Institute
  • University of Texas MD Anderson Cancer CenterRecruiting
  • University of Virginia Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1 and Cohort 3

Cohort 2 and Cohort 4

Arm Description

MT-101

MT-101 preceded by conditioning (lymphodepleting) chemotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

MT-101 cell kinetics in blood
The quantity of MT-101 RNA in the blood.
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)

Full Information

First Posted
November 16, 2021
Last Updated
June 18, 2023
Sponsor
Myeloid Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05138458
Brief Title
A Study of MT-101 in Subjects With CD5+ Relapsed/Refractory TCL
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Myeloid Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Adoptive Cellular Immunotherapy, Cell Therapy
Keywords
T Cell Lymphoma, PTCL, CTCL, MF, MT-101, CD5 chimeric antigen receptor, Myeloid cells, Monocytes, Chimeric Antigen Receptor, CAR Monocyte Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Multi-ascending dose escalation
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 and Cohort 3
Arm Type
Experimental
Arm Description
MT-101
Arm Title
Cohort 2 and Cohort 4
Arm Type
Experimental
Arm Description
MT-101 preceded by conditioning (lymphodepleting) chemotherapy
Intervention Type
Biological
Intervention Name(s)
MT-101
Intervention Description
CD5 ATAK cells
Intervention Type
Other
Intervention Name(s)
MT-101 + Conditioning (Lymphodepleting) Chemotherapy
Intervention Description
IV administration of fludarabine and cyclophosphamide
Primary Outcome Measure Information:
Title
Safety and Tolerability of MT-101
Description
Safety and tolerability of the drug will be determined based on observed adverse events (AEs), including all potential dose limiting toxicities.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
MT-101 cell kinetics in blood
Description
The quantity of MT-101 RNA in the blood.
Time Frame
4 weeks
Title
The objective response rate
Description
The ORR is defined as the number (%) of subjects achieving a best overall response of complete response (CR) or partial response (PR)
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Duration of response (DOR)
Description
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.
Time Frame
48 weeks
Title
Progression free survival (PFS)
Description
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.
Time Frame
48 weeks
Title
Overall survival (OS)
Description
OS is defined as the time from date of the first administration of MT-101 to the date of death.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Operations
Phone
617-465-1026
Email
MT-101clinical@myeloidtx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Gerber, MD, MPH
Organizational Affiliation
Myeloid Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Zain
Phone
626-359-8111
First Name & Middle Initial & Last Name & Degree
Jasmine Zain, MD
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Autumn
Phone
303-883-2714
First Name & Middle Initial & Last Name & Degree
Michael Tees, MD
Facility Name
Miami Cancer Institute at Baptist Health
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guenther Koehne, MD
Phone
786-527-8338
First Name & Middle Initial & Last Name & Degree
Guenther Koehne, MD
Facility Name
Dana-Farber/Mass General Brigham Cancer Care
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvia Jain, MD
Phone
617-724-4000
First Name & Middle Initial & Last Name & Degree
Salvia Jain, MD
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Blumel
Phone
402-559-9183
First Name & Middle Initial & Last Name & Degree
Matthew Lunning, DO, FACP
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Ibrahim
Phone
212-241-6021
First Name & Middle Initial & Last Name & Degree
Uroosa Ibrahim, MD
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Johnson, DO
Phone
646-608-2091
Email
cart@mskcc.org
First Name & Middle Initial & Last Name & Degree
William Johnson, DO
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natisha
Phone
215-955-5769
First Name & Middle Initial & Last Name & Degree
Usama Gergis, MD
Facility Name
Tennessee Oncology / Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Iyer
First Name & Middle Initial & Last Name & Degree
Swaminathan Iyer, MD
Facility Name
University of Virginia Comprehensive Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley
Phone
434-409-5009
First Name & Middle Initial & Last Name & Degree
Enrica Marchi, MD

12. IPD Sharing Statement

Learn more about this trial

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

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