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EHA 2025 | A Phase I study of KITE-363 in patients with R/R B-cell lymphoma
Saurabh Dahiya, MD, FACP, Stanford University School of Medicine, Stanford, CA, shares insights into a Phase I study exploring KITE-363, a novel anti-CD19/CD20 CAR T-cell therapy, in patients with relapsed/refractory (R/R) B-cell lymphoma. Dr Dahiya highlights the background, safety, and efficacy outcomes. This interview took place at the 30th Congress of the European Hematology Association (EHA) in Milan, Italy.
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Transcript
KITE-363 is a dual targeting bispecific CAR T-cell therapy for relapsed/refractory large B-cell lymphoma. In this particular CAR T-cell therapy, the CD19 CAR-T has a CD28 costimulated domain and CD20 CAR-T has a 4-1BB costimulated domain. A third of the patients who get CAR T-cell therapy for large B cell lymphoma with a single antigen targeting CAR T-cell therapy, that’s a CD19 CAR T-cell therapy, experience either antigen downregulation or complete loss of antigen at relapse...
KITE-363 is a dual targeting bispecific CAR T-cell therapy for relapsed/refractory large B-cell lymphoma. In this particular CAR T-cell therapy, the CD19 CAR-T has a CD28 costimulated domain and CD20 CAR-T has a 4-1BB costimulated domain. A third of the patients who get CAR T-cell therapy for large B cell lymphoma with a single antigen targeting CAR T-cell therapy, that’s a CD19 CAR T-cell therapy, experience either antigen downregulation or complete loss of antigen at relapse. In our own experience, that antigen downregulation and antigen escape issue occurs in about a third of the patients. This phase one study of KITE-363 in relapsed/refractory B-cell malignancies primarily enrolled patients with large B-cell lymphoma. This was a dose escalation as well as dose expansion study conducted in Phase Ia and Phase Ib fashion, this was dose escalation done in three by three escalation design. The primary endpoint was dose-limiting toxicity; we did not observe any dose-limiting toxicity in this period in this clinical trial. In terms of safety at the highest dose level for large B-cell lymphoma patients, we did not experience any high-grade cytokine release syndrome or immune-effector cell-associated neurologic syndrome or ICANS, suggesting a very good safety profile with this particular CAR-T product. The efficacy outcomes with this agent in the highest dose level at dose level three, with a dose of CAR T-cell being 2 million per kilogram of CAR positive cells, we observed an objective response rate of 87% and a complete remission rate of 78% percent in relapsed/refractory high-risk large B-cell lymphoma patients. The durability of response was quite good as well. We showed that the median durability of response or DOR has not been reached yet. Point estimated month six was 72 percent, which is quite high as what I would expect in my clinical practice.
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