Kite’s Next-Generation Bicistronic CAR T-Cell Therapies Show Encouraging Phase 1 Results in Relapsed/Refractory B-Cell Lymphoma in New Data at ASH 2025

Kite, a Gilead Company (Nasdaq: GILD), presented Phase 1 data today with encouraging efficacy and safety results for its two investigational bicistronic CAR T-cell therapies, KITE-753 and KITE-363, respectively, in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL). The results of the analysis were shared in an oral presentation (Abstract #265) at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition.

Both KITE-753 and KITE-363 are bicistronic autologous CAR T-cell therapies. They are designed to target two antigens (CD19 and CD20) found on cancer cells and use two co-stimulatory domains (CD28 and 4-1BB) to help the immune system fight cancer more effectively. The KITE DuoCore construct – with two independent CARs working synergistically – may prevent relapse by reducing cancer cells escaping treatment and may help improve safety, making it possible to treat more patients outside of a hospital setting. Additionally, KITE-753 leverages a novel manufacturing process that preserves T-cell fitness. Combined, these attributes may contribute to better efficacy, lower toxicity, durable function, and faster delivery to patients.

"While CAR T-cell therapy has revolutionized treatment for many people with blood cancers, we urgently need options that not only improve upon the curative potential of existing cell therapies for evasive cancers but are also safer and available to a broader patient population,” said Dr. Saurabh Dahiya, MD, FACP, the Stanford School of Medicine. “The encouraging response rates, durability and safety profile of KITE-753 and KITE-363 offer strong clinical evidence to support further development."

The open-label, multicenter, umbrella Phase 1 study enrolled 67 patients with R/R BCL. Thirty patients received KITE-753 and 37 received KITE-363.

Results for KITE-753 showed that at a median follow-up of 4.0 months overall and 2.9 months at dose level three (DL3; 0.2×10⁶ CAR T cells/kg), 11 of 14 CAR-naïve patients (79%) receiving DL3 had a complete response, where the cancer completely disappeared. Bridging options in this Phase 1 study were limited to corticosteroid +/- radiation therapy, and all patients had measurable, active disease at the time of their infusion with KITE-753. No patients responded to these bridging therapy measures at DL3. Notably, KITE-753 demonstrated robust expansion despite a tenfold lower dose than DL3 of KITE-363 (2×10⁶ CAR T cells/kg), which highlights the proliferative capacity of KITE-753. Across all dose levels, 14 of 20 CAR-naïve patients achieved a complete response.