The FDA granted fast track designation to MT-101, an investigational chimeric antigen receptor monocyte, for the treatment of relapsed or refractory peripheral T-cell lymphoma.
MT-101 (Myeloid Therapeutics) is an autologous, CD5-directed monocyte-derived cell therapy that uses messenger RNA (mRNA) engineering to insert a chimeric antigen receptor into the patient’s previously collected myeloid cells.
The FDA’s fast track designation helps to expedite development, review and potential approval of treatments for serious or life-threatening diseases.
“The designation speaks to the serious nature of [CD5-positive relapsed or refractory] peripheral T-cell lymphoma — an aggressive form of non-Hodgkin lymphoma — and the potential MT-101 has to transform the treatment paradigm of this disease,” Michele Gerber, MD, MPH, chief medical officer of Myeloid Therapeutics, said in a company-issued press release.
The phase 1/phase 2 IMAGINE trial is evaluating the safety, tolerability and efficacy of MT-101 for adults with CD5-positive relapsed or refractory peripheral T-cell lymphoma. The multicenter dose-escalation trial will assess MT-101 with or without preconditioning lymphodepleting chemotherapy.
“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, CEO of Myeloid Therapeutics, said in the release. “We remain optimistic [about] the future of MT-101 and its ability to provide improved outcomes [to patients with peripheral T-cell lymphoma].”