David Sallman, MD, on Updates From the AMELI-01 Trial of UCART123v1.2 for AML

“We had 2 patients that had a clinical benefit, 1 had a blast reduction from 60% to 5% and was able to get a donor lymphocyte infusion. The other was quite remarkable and was a personal patient of mine who had high blasts, had a relapse post-transplant and had failed many lines of therapy with horrendous grade 4 cytopenia. She was treated in AMELI-01 and achieved MRD negative complete remission [CR] by the end of the first month and she's now been in a durable MRD negative CR for 1 year without any subsequent therapy, including second transplant or donor lymphocyte infusion. It’s 1 of the most remarkable responses of CAR T in patients with acute myeloid leukemia that I’ve seen.”

UCART123v1.2, in combination with an alemtuzumab plus fludarabine and cyclophosphamide lymphodepleting regimen to improve cell expansion and persistence had a manageable safety profile and yielded responses in patients with acute myeloid leukemia (AML). Data from the AMELI-01 clinical trial (NCT04106076) evaluating the allogeneic chimeric antigen receptor (CAR) T-cell therapy were presented by David Sallman, MD, assistant member, department of malignant hematology, Moffitt Cancer Center at the 64th American Society of Hematology (ASH) Annual Meeting, held December 10-12, 2022, in New Orleans, Louisiana.

CGTLive spoke with Sallman to learn more about the updated data from the trial, including 2 cases of complete remissions. He also discussed working to manage the ongoing challenges with cytokine release syndrome in CAR T-treated patients and next steps for the trial.

REFERENCE

Ameli-01: A Phase I Trial of UCART123v1.2, an Anti-CD123 Allogeneic CAR-T Cell Product, in Adult Patients with Relapsed or Refractory (R/R) CD123+ Acute Myeloid Leukemia (AML). Presented atL 64th ASH Annual Meeting, December 10-12, New Orleans, Louisiana. Abstract #981