Clinical trial NCT05138458: A Study of MT-101 in Subjects With CD5+ Relapsed/Refractory TCL
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
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: Myeloid Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-12-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Multi-ascending dose escalation
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Safety and Tolerability of MT-101
timeFrame: 4 weeks
Secondary outcomes:
measure: MT-101 cell kinetics in blood
timeFrame: 4 weeks
measure: The objective response rate
timeFrame: 24 weeks
Other outcomes:
measure: Duration of response (DOR)
timeFrame: 48 weeks
measure: Progression free survival (PFS)
timeFrame: 48 weeks
measure: Overall survival (OS)
timeFrame: 48 weeks
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Boston
country: United States
facility: Dana-Farber/Mass General Brigham Cancer Care
state: Massachusetts
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Comprehensive Cancer Center
state: Virginia
Study officials:
affiliation: Myeloid Therapeutics
name: Michele Gerber, MD, MPH
role: STUDY_DIRECTOR
References: