Phase 1/2 refractory PTCL therapy.
Myeloid Therapeutics has announced the dosing of the first patient in the Phase I/II IMAGINE Study of its mRNA engineered CAR monocyte (CAR-M), MT-101, to treat refractory or relapsed peripheral T cell lymphoma (PTCL) patients.
The open-label, multicentre, dose-escalation and dose cohort expansion Phase I/II trial will assess MT-101 in patients with refractory or relapsed PTCL, an aggressive form of non-Hodgkin lymphoma.
At present, the Phase I study’s dose-escalation portion, with and without conditioning therapy, is enrolling patients.
A Phase II trial will begin to support registration in this patient population, once Myeloid establishes the recommended dose for this phase.
On day 28, the primary endpoint for tolerability and safety, no cytokine release syndrome (CRS), no dose-limiting toxicities, and no immune effector cell-associated neurotoxicity syndrome (ICANS) were observed in the patient.
Myeloid Therapeutics chief medical officer Michele Gerber said: “We are pleased to announce the initiation of dosing in the IMAGINE clinical trial, which represents a major milestone in our efforts to provide treatment with CD5 ATAK cells for patients with relapsed or refractory PTCL.
“Currently, we are continuing through the dose-escalation cohorts of IMAGINE, which is designed to assess the safety and tolerability, optimal dose regimen, tumor penetration and preliminary efficacy of MT-101 in patients with PTCL.
“Following conclusion of Phase I, we expect to expand quickly into the Phase II portion of this study, which we designed to support registration of MT-101.”
The company’s mRNA-engineered monocyte, MT-101, was advanced from conception and preclinical proof of concept to its first dose in humans in 18 months.