Kite Unveils Promising New Data for Next-Gen CAR T Cell Therapy at ASH 2025

Kite's New CAR T Cell Therapies Show Promise for R/R LBCL

Kite, a subsidiary of Gilead Sciences headquartered in Santa Monica, California, has announced encouraging results from the Phase I clinical trials of its investigational bispecific CAR T cell therapies, KITE-753 and KITE-363, aimed at treating relapsed/refractory large B-cell lymphoma (R/R LBCL). These promising results were presented at the 67th Annual Meeting & Exposition of the American Society of Hematology (ASH) in December 2025, highlighting the potential of these innovative treatments.

Study Overview and Background

The trials for KITE-753 and KITE-363 involved a total of 67 patients diagnosed with R/R LBCL, a prevalent form of non-Hodgkin lymphoma, affecting over 18,000 individuals annually in the United States alone. Notably, 30 patients received KITE-753, while 37 were treated with KITE-363. Both therapies are designed to target two specific antigens, CD19 and CD20, using two co-stimulatory domains (CD28 and 4-1BB), which enhances the immune response against cancer cells.

The trials were designed to overcome the heterogeneous nature of tumor antigens and prevent relapse. The unique DuoCore™ structure of these therapies helps to minimize the escape of cancer cells meant to evade treatment, thereby boosting safety and improving the likelihood of outpatient administration for a broader patient population.

Efficacy Results of KITE-753

In the KITE-753 cohort, initial observations showed a remarkable complete response (CR) rate. Out of 14 patients treated at dose level 3 (DL3, 0.2×10^6 CAR T cells/kg), 11 achieved CR, amounting to a 79% complete response rate. This high efficacy was observed during a median follow-up period of 4 months, specifically demonstrating a robust proliferation potential in a pivotal treatment scenario.

The overall favorable profile for KITE-753 was significant, with no dose-limiting toxicities noted. At DL3, serious toxicities such as grade 3 or higher cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) were absent, indicating a promising safety profile suitable for further exploration.

Expert Insights

Dr. Saurabh Dahiya from Stanford University School of Medicine voiced the importance of these findings, stating that CAR T cell therapies have revolutionized treatment for many blood cancer patients. Emphasizing the need for safer and broader treatment options, he pointed out that the strong clinical evidence supporting KITE-753 and KITE-363 can significantly improve existing cell therapies for resistant malignancies.

Safety Profile of KITE-363

The KITE-363 therapy also showed a durable benefit for patients with no prior CAR T treatment. An impressive 70% of patients maintained a CR at 12 months during the median follow-up of 17.5 months, with a strong tolerance reported throughout the trial, with no significant trial-halt inducing side effects observed. The adverse events primarily consisted of grade 3 CRS and ICANS, with no grade 4 or higher incidents reported.

Conclusion and Future Directions

Kite is determined to expand the frontiers of CAR T technology through innovative design and optimized manufacturing processes. Dr. Gallia Levy, Kite’s Senior Vice President, highlighted the objective of delivering these groundbreaking therapies to patients with progressive diseases who lack alternative treatment options, particularly emphasizing the outpatient treatment potential of these new therapies.

With the ongoing development and exploratory nature of KITE-753 and KITE-363, the prospect for improving outcomes in R/R LBCL patients seems promising, setting a new benchmark for CAR T therapies in hematologic cancers. The future clinical landscape could see a significant shift, providing hope to patients who have limited options in the face of aggressive malignancies.