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ASH 2025 | Phase I study of KITE-753 or KITE-363 in patients with R/R B-cell lymphoma
Saurabh Dahiya, MD, FACP, Stanford University School of Medicine, Stanford, CA, discusses the results of a Phase I study (NCT04989803) investigating KITE-753 and KITE-363 in patients with relapsed/refractory (R/R) B-cell lymphoma, highlighting the updated data for KITE-363 and the preliminary results of KITE-753. Both products demonstrated encouraging efficacy in a high-risk patient population, and Dr Dahiya notes that plans are underway to move these trials to registrational studies in the large B-cell lymphoma (LBCL) setting. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
So we presented the results, the updated results of the KITE-363 product and preliminary results of the KITE-753 product. KITE-363 is a dual targeting, bicistronic, dual core design CAR-T cell product targeted against CD19 and CD20. It is manufactured in a conventional fashion in about 67-day manufacturing. KITE-753 is a rapid manufacturing platform where it’s manufactured over a shorter time to preserve the juvenile stem cell memory as well as naive T-cell functionality in the CAR T-cell product...
So we presented the results, the updated results of the KITE-363 product and preliminary results of the KITE-753 product. KITE-363 is a dual targeting, bicistronic, dual core design CAR-T cell product targeted against CD19 and CD20. It is manufactured in a conventional fashion in about 67-day manufacturing. KITE-753 is a rapid manufacturing platform where it’s manufactured over a shorter time to preserve the juvenile stem cell memory as well as naive T-cell functionality in the CAR T-cell product.
We presented the updated results of 363 where we showed that there was no new safety signal for the KITE-363 product. The 363 product continued to show durable remission at up to 18 month mark with the durability of complete response that is maintained in over 70% of the patients. These are very high-risk patient population, with more than 70% of the patients having primary refractory disease and about 70% of the patients with high LDH at the time they got CAR T-cell therapy. So that was a very exciting result.
KITE-753 data was presented for the first time at this meeting at ASH 2025, where we showed that we see a very high response rate in this patient population with refractory and relapsed B-cell lymphomas. We show a very high objective overall response rate at 81% and a complete remission rate of 79%. The efficacy endpoints were quite impressive for both the products with very high objective response rate and CR rate. Specifically for KITE-753, it was upwards of 80% in a very refractory patient population. These trials are going to move to third-line registrational trial in large B-cell lymphoma setting, and also a second-line randomized control trial is also planned in early 2026.
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