MT-101 Granted Fast Track Designation by FDA for CD5+ Relapsed/Refractory Peripheral T-Cell Lymphoma

The FDA has granted fast track designation to MT-101 for the treatment of patients with CD5-positive relapsed/refractory peripheral T-cell lymphoma (PTCL), according to a press release from Myeloid Therapeutics.

MT-101 is being assessed as part of the phase 1/2 IMAGINE trial (NCT05138458) in patients with CD5-positive T-cell malignancies. The agent is an mRNA engineered CAR monocyte created from the proprietary ATAK platform. MT-101 is delivered with a vein-to-vein time of 8 days. The agent targets CD5, which is expressed in the majority of PTCL cases, and was designed to employ the power of myeloid cells to penetrate tumors and initiate anti-tumor activity.

“We are pleased that MT-101 has received fast track designation from the FDA," Michele Gerber, MD, MPH, chief medical officer at Myeloid, said in the press release. “The designation speaks to the serious nature of CD5-positive relapsed/refractory PTCL, an aggressive form of non-Hodgkin lymphoma, and the potential MT-101 has to transform the treatment paradigm of this disease. IMAGINE, a phase 1/2 trial assessing safety, tolerability, and efficacy of MT-101 in this indication is open for enrollment and the initial data is very encouraging.”

The goal of the multicenter, open-label, first-in-human study is to evaluate multiple doses of MT-101 in the dose escalation portion. Once the recommended phase 2 dose has been determined, investigators will begin the phase 2 portion. The study has an estimated enrollment of 40 patients and will be assessing MT-101 alone and with the addition of lymphodepleting chemotherapy.

The primary end point is the safety and tolerability of MT-101 as determined by observed adverse effects, with secondary outcome measures including the quantity of MT-101 RNA in the blood. Other outcomes to be assessed include duration of response, progression-free survival, and overall survival.

To be eligible for the study, patients needed to have been diagnosed with relapsed/refractory T-cell lymphoma, such as PTCL not otherwise specified, angioimmunoblastic T-cell lymphoma, ALK-negative anaplastic large cell lymphoma (ALCL), ALK-positive ALCL, or stage IIB to IV mycosis fungoides including large cell transformation. CD5 expression, an ECOG performance status of 2 or less, and adequate organ function were also required for inclusion.

“MT-101 is the first mRNA engineered monocyte cell product to receive Fast Track designation from the FDA, representing a tremendous milestone for Myeloid and the broader field of cell therapy,” Daniel Getts, PhD, chief executive officer at Myeloid, concluded. “We continue to demonstrate our ability to manufacture scalable and cost-effective cell therapy products and deliver them expeditiously to the clinic. We remain optimistic on the future of MT-101 and its ability to provide PTCL patients with improved outcomes.”

Reference

Myeloid Therapeutics announces FDA fast track designation for MT-101 for the treatment of CD5+ relapsed/refractory PTCL. News release. Myeloid Therapeutics. October 27, 2022. Accessed October 27, 2022. http://bit.ly/3FEVuTh