The FDA has lifted the clinical hold on the planned trial investigating the safety and efficacy of the novel multi-tumor associated antigen (MultiTAA) T-cell therapy in patients with post-transplant acute myeloid leukemia (AML), according to Marker Therapeutics, the agent’s developer.
A hold on the trial was previously announced on November 12, 2019, after the FDA requested additional information and technical specifications for 2 legacy reagents supplied by third parties used in the manufacturing process of the T-cell product that could not be produced by the original suppliers. Marker has since identified alternative suppliers, fulfilling the agency’s request.
Based on data the company provided, the FDA has allowed the company to launch its AML trial, starting with a safety lead-in portion. However, a partial clinical hold was placed by the FDA on the trial for the use of the MultiTAA-specific T-cell product that was manufactured using one of the reagents provided by the alternative supplier until the final data and certificate of analysis for the reagent is reviewed and accepted by the agency.
“With a clear path identified for getting our study of MultiTAA-specific T-cell therapy underway in patients with AML, we’re focused on addressing the remaining requirements from the FDA and enrolling up to 20 clinical centers to conducts our phase II trial,” Peter L. Hoang, president and chief executive officer of Marker Therapeutics, said in a press release. “We appreciate the productive dialogue with the FDA throughout the process and look forward to advancing MultiTAA-specific T-cell therapy for patients with post-transplant AML in a randomized and multicenter clinical trial.”
The safety lead-in segment of the trial is anticipated to enroll approximately 6 patients as part of the amended trial design. Three patients will be dosed with MultiTAA-specific T-cells created using the legacy reagent, and 3 patients will be dosed with T-cells produced using the reagent from the alternative supplier.
It is currently estimated that the alternative supplier will provide the final reagent, as well as the final data and certificate of analysis needed by the FDA, by the end of the second quarter of 2020. Additionally, Marker expects to complete enrollment of the first 3 patients and submission of the final technical specifications and comparability data of the new reagents to the FDA during the second half of 2020, which would satisfy the qualifications for lifting the partial hold on the trial. Taking this timeline into consideration, the company indicated that they do not believe the partial clinical hold will significantly affect site and patient enrollment of the AML trial.
Following the safety lead-in will be a 160-patient randomized portion of the study, which will be conducted at approximately 20 transplant centers. Group 1 will consist of 120 adjuvant patients, with a primary endpoint of relapse-free survival of patients receiving MultiTAA-specific T-cell therapy vs a control group. Group 2 will include 40 active disease patients in a single arm, with primary endpoints of complete remission and duration of complete remission.
Marker Therapeutics Announces Update to its Clinical Program in AML [news release]. Houston, Texas. Published February 11, 2020. prnewswire.com/news-releases/marker-therapeutics-announces-update-to-its-clinical-program-in-aml-301002402.html. Accessed February 12, 2020.