BY: Kerri Fitzgerald
Patients with CD30-positive lymphoma who become refractory to brentuximab vedotin and anti-PD1 checkpoint inhibitors have limited options and poor outcomes, so researchers sought to assess a new therapeutic for this cohort.
A CD30/CD16A bispecific antibody, AFM13, “showed encouraging preliminary safety and efficacy,” according to Yago Nieto, MD, PhD, of the University of Texas MD Anderson Cancer Center, and colleagues who published their findings in Nature Medicine.
The researchers studied cord-blood-derived cytokine-preactivated and expanded natural killer (NK) cells precomplexed with AFM13.
The phase 1 trial included 42 heavily pretreated patients with CD30-positive lymphoma who were refractory to brentuximab vedotin and checkpoint inhibitors who received 2 to 4 cycles of lymphodepletion followed by AFM13-NK cell infusion at 3 dose levels: 1×106 kg−1, 1×107 kg−1, or 1×108 kg−1 plus three weekly AFM13 infusions.
There were no reports of cytokine release syndrome, neurotoxicity, or graft-versus-host disease. The 1×108 kg−1 dose was recommended for phase 2 testing.
Donor NK cells peaked in the blood one day after infusion and persisted for up to three weeks.
The overall response rate was 92.9%, and the complete response (CR) rate was 66.7%. At a median follow-up of 20 months, the two-year event-free and overall survival rates were 26.2% and 76.2%, respectively. Eleven patients maintained a CR at 14 to 40 months.
Reference
Nieto Y, Banerjee P, Kaur I, et al. Allogeneic NK cells with a bispecific innate cell engager in refractory relapsed lymphoma: a phase 1 trial. Nat Med. 2025. doi:10.1038/s41591-025-03640-8
