NCT05138458

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2021

Typical duration for phase_1

Geographic Reach
1 country

6 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2.9 years

First QC Date

November 16, 2021

Last Update Submit

November 9, 2023

Conditions

Lymphoma, T-Cell, PeripheralLymphoma, T-Cell, CutaneousMycosis FungoidesAdoptive Cellular ImmunotherapyCell Therapy

Keywords

T Cell LymphomaPTCLCTCLMFMT-101CD5 chimeric antigen receptorMyeloid cellsMonocytesChimeric Antigen ReceptorCAR Monocyte Therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • MT-101 cell kinetics in blood

    4 weeks

  • The objective response rate

    24 weeks

Other Outcomes (3)

  • Duration of response (DOR)

    48 weeks

  • Progression free survival (PFS)

    48 weeks

  • Overall survival (OS)

    48 weeks

Study Arms (2)

Cohort 1 and Cohort 3

EXPERIMENTAL

MT-101

Biological: MT-101

Cohort 2 and Cohort 4

EXPERIMENTAL

MT-101 preceded by conditioning (lymphodepleting) chemotherapy

Other: MT-101 + Conditioning (Lymphodepleting) Chemotherapy

Interventions

MT-101BIOLOGICAL

CD5 ATAK cells

Cohort 1 and Cohort 3
MT-101 + Conditioning (Lymphodepleting) ChemotherapyOTHER

IV administration of fludarabine and cyclophosphamide

Cohort 2 and Cohort 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Dana-Farber/Mass General Brigham Cancer Care

Boston, Massachusetts, 02215, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, PeripheralLymphoma, T-Cell, CutaneousMycosis FungoidesLymphoma, T-Cell

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Michele Gerber, MD, MPH

    Myeloid Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Multi-ascending dose escalation
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

December 1, 2021

Study Start

December 15, 2021

Primary Completion

November 1, 2024

Study Completion

October 1, 2025

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations

US(6)