FDA Grants Fast Track Designation to MT-101 for CD5+ Relapsed/Refractory PTCL

FDA

The FDA has granted a fast track designation to MT-101 for use as a potential therapeutic option in patients with relapsed or refractory, CD5-positive peripheral T-cell lymphoma (PTCL), according to an announcement from Myeloid Therapeutics, Inc.¹

Derived from the company’s ATAK^™ platform, MT-101 is a mRNA-engineered CAR monocyte that is administered with a vein-to-vein time of 8 days. The product targets CD5, which is a surface receptor that is found in more than 75% of PTCL cases. Notably, MT-101 was designed to harness the ability of myeloid cells to infiltrate tumors, and to encourage extensive antitumor activity.

With this designation, Myeloid Therapeutics may benefit from early and frequent communication with the regulatory agency. The agent is also eligible for rolling submission and review of the marketing application.

“We are pleased that MT-101 has received fast track designation from the FDA,” Michele Gerber, MD, PhD, chief medical officer of Myeloid Therapeutics, Inc., stated in a 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.”

The safety and efficacy of the agent is under exploration in the multicenter, open-label, first-in-human, phase 1/2 IMAGINE trial (NCT05138458).² To be eligible for enrollment, patients are required to have a CD5-expressing, relapsed or refractory, pathologically confirmed T-cell lymphoma; this can include PTCL not otherwise specified, angioimmunoblastic T-cell lymphoma, ALK-positive or -negative anaplastic large cell lymphoma, or mycosis fungoides stage IIB to IV disease, including those with large cell transformation.

Patients also need to be over 18 years of age, have an ECOG performance status that is less than 2, and acceptable organ function.

Those with B1 and B2 disease; known central nervous system involvement; a history of allogeneic transplant or intolerance to leukapheresis, plasmapheresis, or blood donation; an acute illness including fever; active systemic bacterial, fungal, or viral infection or another chronic infection; or other primary malignancies, they were excluded.

The study is comprised of 2 parts. In the first portion of the research, investigators will examine the safety and tolerability of MT-101 in 4 groups of patients:

• The first group will be administered a low dose of cells
• The second group will receive a low dose of cells plus lymphodepletion chemotherapy to reduce the number of T cells in the blood
• The third group will receive a higher dose of cells
• The fourth group will be administered a higher dose of cells plus lymphodepletion chemotherapy to reduce the number of T cells in the blood

For the second portion of the research, investigators will give the cells with or without chemotherapy to patients based on the data yielded from part 1. Here, the safety, tolerability, and efficacy of the agent will be further explored.

All participants will be given 6 doses of MT-101 over a 3-week period.

The primary outcome measure for the trial is to evaluate the safety and tolerability of the agent, and key secondary outcome measures include examining MT-101 cell kinetics in the blood and the objective response rate achieved with the product. Other outcome measures include duration of response, progression-free survival, and overall survival.

The dose-escalation portion of the trial is open and enrolling patients. Once the recommended phase 2 dose of MT-101 is identified, the phase 3 portion will launch to support registration in this population.

“MT-101 is the first mRNA engineered monocyte cell produce 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 of Myeloid Therapeutics, Inc., added in the press release. “We continue to demonstrate our ability to manufacture scalable and cost-effective cell therapy products and deliver them expeditiously to the clinic.”

References

1. Myeloid Therapeutics announces FDA fast track designation for MT-101 for the treatment of CD5+ relapsed/refractory PTCL. News release. October 27, 2022. Accessed October 31, 2022. https://prn.to/3fmKG1b
2. A study of MT-101 in subjects with CD5+ relapsed/refractory TCL (IMAGINE). ClinicalTrials.gov. Updated October 13, 2022. Accessed October 31, 2022. https://www.clinicaltrials.gov/ct2/show/NCT05138458