Schedule of examine therapy and correlative sampling. Credit score: Nature Drugs (2025). https://www.nature.com/articles/s41591-025-03640-8
A novel cell remedy method utilizing twine blood-derived pure killer (NK) cells pre-complexed with AFM13, or acimtamig, a CD30/CD16A bispecific antibody, was protected and generated robust response charges for sufferers with refractory CD30-positive lymphomas, in line with a brand new examine from The College of Texas MD Anderson Most cancers Middle.
Outcomes from the Part I trial, printed in Nature Drugs, demonstrated an general response price of 92.9% and a whole response of 66.7% in 42 closely pretreated sufferers.
These findings recommend this distinctive cell remedy method has promise for particular sufferers with lymphoma, however it could be tailored for extra most cancers varieties sooner or later.
“We observed rapid and strong responses to this novel approach of treating patients with AFM13-NK, and we continue to evaluate the efficacy of this therapy for these hard-to-treat malignancies,” stated principal investigator Yago Nieto, M.D., Ph.D., professor of Stem Cell Transplantation & Mobile Remedy.
“These data lend to this approach being considered as a possible curative treatment for some patients and a bridge to a stem cell transplant for others.”
The trial’s novel method makes use of Affimed’s AFM13 bispecific antibody, which is designed to bind to CD16A on NK cells and CD30 on lymphoma cells. Due to this fact, pre-complexed AFM13-NK cells are extra readily capable of finding and get rid of CD30-positive lymphoma cells.
The NK cells are first activated with cytokines, expanded within the presence of synthetic antigen-presenting cells and complexed with AFM13 earlier than being infused right into a affected person.
The method was first developed within the laboratory of collaborating creator Katy Rezvani, M.D., Ph.D., Sally Cooper Murray Endowed Chair in Most cancers Analysis, professor of Stem Cell Transplantation & Mobile Remedy, and vp and head of MD Anderson’s Institute for Cell Remedy Discovery & Innovation. By way of the institute, Rezvani and her crew proceed to develop and advance impactful cell therapies for quite a lot of circumstances.
This trial enrolled 37 grownup sufferers with CD30-positive Hodgkin lymphoma and 5 with T-cell lymphoma. Sufferers have been closely pretreated and have been refractory to brentuximab vedotin and anti-PD1 immune checkpoint inhibitors. The median age for trial contributors was 43 years. Sufferers had obtained a median of seven prior traces of remedy.
Trial contributors have been handled with two to 4 cycles of chemotherapy adopted by AFM13-NK cell infusion at three dose ranges and three weekly infusions. At day 28 of every cycle, every affected person’s response to therapy was evaluated, with a follow-up evaluation each three months thereafter.
The general response price (ORR) and full response (CR) in examine sufferers was 92.9% and 66.7%, respectively. Amongst sufferers with Hodgkin lymphoma, the ORR and CR have been 97.3% and 73%, respectively. At a median follow-up of 20 months, the two-year event-free survival (EFS) and general survival (OS) charges for all contributors have been 26.2% and 76.2%, respectively, which is encouraging given the closely pretreated and refractory nature of the sufferers’ tumors.
The median EFS was 8.8 months, and median OS had not but been reached at information cut-off—a sign of constructive outcomes.
Eleven sufferers remained in full response for a minimum of 14 months, and a few remained in full response as much as 40 months post-therapy. 5 sufferers maintained their full remission with none further remedy, and 6 went on to obtain a stem cell transplant.
The AFM13-NK cell therapy was effectively tolerated, with no recognized circumstances of cytokine launch syndrome, immune cell-associated neurotoxicity syndrome or graft-versus-host illness. There was one case of Grade 2 infusion-related response.
Wire blood models for every cycle, used for the NK cells, have been chosen from the MD Anderson Most cancers Middle Wire Blood Financial institution and chosen based mostly on the standards beforehand recognized for optimum twine blood models. Donor NK cells peaked in sufferers’ blood someday post-infusion and endured for as much as three weeks and trafficked to tumor websites.
“Our trial showed the favorable safety profile and encouraging activity of AFM13-NK cells in patients with heavily pretreated refractory CD30-positive Hodgkin lymphoma,” stated Nieto.
“This approach, involving cytokine-induced memory cord blood-derived NK cells precomplexed with AFM13, not only holds promise for the treatment of Hodgkin lymphoma but also supports future research into the clinical applications of NK cells with bispecific engagers.”
Extra info:
Yago Nieto et al, Allogeneic NK cells with a bispecific innate cell engager in refractory relapsed lymphoma: a part 1 trial, Nature Drugs (2025). DOI: 10.1038/s41591-025-03640-8. www.nature.com/articles/s41591-025-03640-8
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College of Texas M. D. Anderson Most cancers Middle
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NK cells with bispecific antibody yield excessive response charges in sufferers with lymphoma: Medical trial (2025, April 4)
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