Dr. Sallman on the Responses to PRGN-3006 in Select AML and Higher-Risk MDS

David Sallman, MD, assistant member, Department of Malignant Hematology, Moffitt Cancer Center, discusses responses achieved in a first-in-human dose escalation/dose expansion phase 1/1b clinical trial (NCT03927261) of an UltraCAR-T agent, PRGN-3006, in patients with acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome with hypomethylating agent failure.

A cohort of 6 patients who received lymphodepletion with fludarabine 30 mg/m2 and cyclophosphamide at 500 mg/m2 on days -5 to -3 and PRGN-3006 experienced encouraging responses with the agent, according to Sallman. Specifically, 3 patients achieved a response to treatment based on European LeukemiaNet criteria, Sallman says.

One patient subsequently underwent a successful allogeneic stem cell transplant (ASCT) and experienced a complete response (CR) with hematologic recovery for over 1 year, Sallman explains. Another patient with extramedullary AML achieved a partial response at day 28, Sallman adds. This patient may be the first with myeloid sarcoma to receive treatment with a novel CAR T-cell therapy, according to Sallman. A third patient, who experienced a post-ASCT relapse, achieved a CR with incomplete hematological recovery; this response also persisted for approximately 3 months, Sallman says.

These are early data with PRGN-3006, but they are intriguing and more information on this approach is anticipated, Sallman concludes.