MT-101 is designed for quick delivery to patients with a vein-to-vein time of 8 days.
Myeloid Therapeutics’ MT-101, an investigational autologous mRNA engineered chimeric antigen receptor (CAR) monocyte therapy, has received fast track designation from the FDA for the treatment of patients with relapsed or refractory (r/r) CD5+ peripheral T-cell lymphoma (PTCL).
MT-101 targets CD5 and is based on the company’s ATAK platform, which "when applied to a therapeutic candidate, the immunotherapy recognizes cancer cells, alters the tumor microenvironment, produces anti-tumor cytokines, promotes anti-tumor adaptive immunity, and ultimately, kills cancer." MT-101 is designed for quick delivery to patients with a vein-to-vein time of 8 days. It is currently being investigated in the phase 1/2 IMAGINE (NCT05138458) clinical trial.
“We are pleased that MT-101 has received fast track designation from the FDA,” Michele Gerber, MD, MPH, chief medical officer, Myeloid Therapeutics, said in a statement. “The designation speaks to the serious nature of CD5+ r/r 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 multicenter, open-label, multiple ascending dose IMAGINE trial will enroll approximately 40 patients aged 18 years or older who have been diagnosed with r/r PTCL, 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. Participants are required to have a CD5-expressing tumor at screening or within 3 months of screening, an Eastern Cooperative Oncology Group performance status less than 2, and adequate organ function. Patients with central nervous system involvement by PTCL; B1 and B2 disease as defined in the protocol for patients with MF; a history of allogeneic transplant; a history of intolerance to leukapheresis, plasmapheresis, or blood donation; or a history of hemophagocytic lymphohistiocytosis will be excluded from the study. Additional exclusion criteria relate to patient health status.
Participants will be divided across 4 cohorts and 2 arms, with a low dose cohort and a high dose cohort receiving conditioning (lymphodepleting) chemotherapy before MT-101 and a low dose cohort and a high dose cohort receiving MT-101 alone. All participants will receive 6 doses of MT-101 in total over the course of 3 weeks. The study’s primary end point is the occurrence of adverse events, including potential dose limiting toxicities. Secondary end points include the quantity of MT-101 RNA in the blood and the objective response rate. Other end points include duration of response, progression-free survival, and overall survival. The study is recruiting at locations in California, Colorado, Florida, Massachusetts, Tennessee, and Virginia and is estimated to be completed in October 2024.
“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, Myeloid, added to the statement. “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.”