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ASH 2025 | Phase I study evaluating NT-I7 (efineptakin alfa) following standard of care CD19 CAR-T in R/R LBCL
Zachary Crees, MD, Washington University School of Medicine, St. Louis, discusses a Phase I study (NCT05075603) evaluating the long-acting IL-7 cytokine NT-I7 (efineptakin alfa) administered after standard-of-care CD19 CAR T-cell therapy in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL). Dr Crees explains that NT-I7 was administered to enhance CAR T-cell expansion and persistence, with the hopes of improving response rates without increasing toxicity. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
So the study that we’re presenting as an oral abstract is a study where we looked at the long-acting IL-7 cytokine called NTI-7, given after infusion of standard of care CD19 CAR T-cell therapies for large B-cell lymphoma. So that would be tisagenlecleucel, axicabtagene ciloleucel, and lisocabtagene maraleucel. And so the premise of the study was that we know that CAR T-cell therapies for CD19-positive B-cell malignancies work very well...
So the study that we’re presenting as an oral abstract is a study where we looked at the long-acting IL-7 cytokine called NTI-7, given after infusion of standard of care CD19 CAR T-cell therapies for large B-cell lymphoma. So that would be tisagenlecleucel, axicabtagene ciloleucel, and lisocabtagene maraleucel. And so the premise of the study was that we know that CAR T-cell therapies for CD19-positive B-cell malignancies work very well. They improve overall survival. But for folks who relapse after the CAR T-cell therapy, outcomes are very poor, and we have relatively few effective therapies. And so the idea was, what can we do to increase the effectiveness of these standard-care therapies? And one of the things that we know from the pivotal studies is that increased expansion and persistence of the CAR19 leads to better overall response rates and improved survival outcomes. So the concept was, could we add this IL-7 cytokine in addition to the standard-of-care CD19 CAR T-cell therapy to improve outcomes without increasing risk of toxicity.
So what we saw as the results of that study is that the addition of NTI-7, the long-acting IL-7 cytokine after standard of care CD19 CAR-T, improved overall response rates and complete response rates relative to what we’ve observed in the historical data from the pivotal studies. And in fact, did so without increasing toxicity. So we saw no treatment-emergent cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome after the IL-7 cytokine had been given. We also saw no dose-limiting toxicities and no grade three or higher adverse effects from the NTI-7. So the study, which was a phase one study, was pretty clear that it can be safely, the NTI-7 can be safely given after CAR-T 19 without increasing toxicities and may improve outcomes. And so that’s the subject of a follow-up study that we currently have planned and will be opening in the first quarter of 2026.
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