IMAGINE: A Study of MT-101 in Subjects With CD5+ Relapsed/Refractory PTCL

Sponsor

Myeloid Therapeutics (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05138458

Collaborator

(none)

Enrollment

Locations

Arms

33.5

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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 Peripheral 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
Peripheral T Cell Lymphoma (PTCL) 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 3 groups of study patients. The first group of patients will receive a low dose of cells, the second group will receive a higher dose of cells, and the third 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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Multi-ascending dose escalationMulti-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 Peripheral T Cell Lymphoma

Actual Study Start Date :

Dec 15, 2021

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Cohort 1 and Cohort 2

MT-101

Biological: MT-101

CD5 ATAK cells

Experimental: Cohort 3

MT-101 preceded by conditioning (lymphodepleting) chemotherapy

Other: MT-101 + Conditioning (Lymphodepleting) Chemotherapy

IV administration of fludarabine and cyclophosphamide

Outcome Measures

Primary Outcome Measures

Safety and Tolerability of MT-101 [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

MT-101 cell kinetics in blood [4 weeks]
The quantity of MT-101 RNA in the blood.
The objective response rate [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

Duration of response (DOR) [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.
Progression free survival (PFS) [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.
Overall survival (OS) [48 weeks]
OS is defined as the time from date of the first administration of MT-101 to the date of death.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Adults age > or equal to18 at the time the Informed Consent is signed.
Refractory or relapsed pathologically confirmed Peripheral T Cell Lymphoma (PTCL): Peripheral T cell Lymphoma not otherwise specified (PTCL-NOS) , Angioimmunoblastic T cell Lymphoma (AITL), ALK-negative anaplastic large cell lymphoma (ALCL), or ALK-positive ALCL
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:

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)
Active systemic bacterial, fungal, or viral infection
Active chronic infection
Other primary malignancies, except adequately treated malignancies or complete remission.
Active or history of autoimmune disease or immunodeficiency.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010
2	Colorado Blood Cancer Institute	Denver	Colorado	United States	80218
3	Tennessee Oncology / Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
4	University of Virginia Comprehensive Cancer Center	Charlottesville	Virginia	United States	22908