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Trial record 1 of 1 for:    NCT05138458
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A Study of MT-101 in Subjects With CD5+ Relapsed/Refractory TCL (IMAGINE)

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ClinicalTrials.gov Identifier: NCT05138458
Recruitment Status : Recruiting
First Posted : December 1, 2021
Last Update Posted : October 13, 2022
Sponsor:
Information provided by (Responsible Party):
Myeloid Therapeutics

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.

Condition or disease Intervention/treatment Phase
Lymphoma, T-Cell, Peripheral Lymphoma, T-Cell, Cutaneous Mycosis Fungoides Adoptive Cellular Immunotherapy Cell Therapy Biological: MT-101 Other: MT-101 + Conditioning (Lymphodepleting) Chemotherapy Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Multi-ascending dose escalation
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 15, 2021
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : October 2024


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. MT-101 cell kinetics in blood [ Time Frame: 4 weeks ]
    The quantity of MT-101 RNA in the blood.

  2. 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)


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05138458


Contacts
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Contact: Clinical Operations 617-465-1026 MT-101clinical@myeloidtx.com

Locations
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United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Contact: Dr. Zain    626-359-8111      
Principal Investigator: Jasmine Zain, M.D.         
United States, Colorado
Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
Contact: Autumn    303-883-2714      
Principal Investigator: Michael Tees, M.D.         
United States, Florida
Miami Cancer Institute at Baptist Health Recruiting
Miami, Florida, United States, 33176
Contact: Guenther Koehne, MD    786-527-8338      
Principal Investigator: Guenther Koehne, MD         
United States, Massachusetts
Dana-Farber/Mass General Brigham Cancer Care Recruiting
Boston, Massachusetts, United States, 02215
Contact: Salvia Jain, MD    617-724-4000      
Principal Investigator: Salvia Jain, MD         
United States, Tennessee
Tennessee Oncology / Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: AskSarah    844-482-4812      
Principal Investigator: Ian Flinn, M.D.         
United States, Virginia
University of Virginia Comprehensive Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Ashley    434-409-5009      
Principal Investigator: Enrica Marchi, MD         
Sponsors and Collaborators
Myeloid Therapeutics
Investigators
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Study Director: Michele Gerber, MD, MPH Myeloid Therapeutics
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Responsible Party: Myeloid Therapeutics
ClinicalTrials.gov Identifier: NCT05138458    
Other Study ID Numbers: MTX-TCL-101
First Posted: December 1, 2021    Key Record Dates
Last Update Posted: October 13, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Myeloid Therapeutics:
T Cell Lymphoma
PTCL
CTCL
MF
MT-101
CD5 chimeric antigen receptor
Myeloid cells
Monocytes
Chimeric Antigen Receptor
CAR Monocyte Therapy
Additional relevant MeSH terms:
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Mycoses
Lymphoma
Mycosis Fungoides
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bacterial Infections and Mycoses
Infections
Lymphoma, Non-Hodgkin