KITE-753 / Gilead, Kite Pharma - LARVOL DELTA

A Multicenter Phase 1 Study of KITE-753 in Patients With Relapsed/Refractory B-Cell Lymphoma: Updated Safety and Efficacy Results (SOHO 2026) - "KITE-753 demonstrated high CR rates in CAR-T–naïve patients and a favorable safety profile, with only low-grade CRS and ICANS at the highest DL. BCL: B-cell lymphoma, CD: cluster of differentiation, CR: complete response, CRS: cytokine release syndrome, DL: dose level, ICANS: immune effector cell–associated neurotoxicity syndrome, ORR: overall response rate, R/R: relapsed/refractory. This abstract was accepted and previously presented at the 2026 European Hematology Association Annual Congress."

Clinical • P1 data • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Phase 1 Study Of KITE-753 in R/R B-Cell ALL (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

New P1 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Leukemia • Oncology • CD20

A PHASE 1 STUDY OF KITE-753 IN PATIENTS (PTS) WITH RELAPSED/REFRACTORY (R/R) B-CELL LYMPHOMA: UPDATED SAFETY AND EFFICACY RESULTS (EHA 2026) - "In a comparative analysis of KITE-753 vs axicabtagene ciloleucel (axi-cel; ZUMA-1), levels of the neurotoxicity-associated cytokine, IL-15, were lower with KITE-753, coinciding with an improved toxicity profile. These favorable pharmacokinetic and pharmacodynamic profiles may reflect KITE-753's optimized CAR T-cell dose that mitigates toxicity and its rapid manufacturing process that preserves CAR T-cell fitness. Summary/Conclusion KITE-753, with a unique CAR design and rapid manufacturing process preserving a naive T-cell phenotype, at the highest DL showed high CR rates in CAR-naive pts and a favorable safety profile with only low-grade CRS and ICANS."

Clinical • P1 data • B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • CD20 • GZMB • IL15 • IL2

KITE-753: A phase 2 study of an autologous anti-CD19/CD20 CAR T-cell therapy in CAR-naive patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL). (ASCO 2026) - P1/2 | "CAR T-cell expansion was comparable to KITE-363 and axi-cel despite a 10-fold lower dose (Dahiya et al... In this open-label, multicenter, single-arm study, patients will undergo leukapheresis and receive optional bridging therapy, followed by lymphodepleting chemotherapy (cyclophosphamide [300 mg/m2/day] and fludarabine [30 mg/m2/day]) from Day -5 to Day -3, and infusion of KITE-753 at a target dose of 2×105 CAR T cells/kg on Day 0...Key exclusion criteria are prior CAR T-cell therapy or active central nervous system involvement from lymphoma. This study is currently open and actively accruing patients (NCT04989803)."

CAR T-Cell Therapy • Clinical • P2 data • B Cell Lymphoma • Hematological Malignancies • Indolent Lymphoma • Large B Cell Lymphoma • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Primary Mediastinal Large B-Cell Lymphoma

Key presentations at EHA include: KITE-753 Phase 1 Study (Businesswire) - "Updated Phase 1 results for KITE-753, Kite’s enhanced DuoCore CAR T-cell therapy for relapsed/refractory B-cell lymphoma, showing encouraging safety and durability of efficacy results that support its continued development (Abstract #4208619)."

P1 data • B Cell Lymphoma

Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy (clinicaltrials.gov) - P3 | N=550 | Recruiting | Sponsor: Kite, A Gilead Company | Not yet recruiting ➔ Recruiting

Enrollment open • B Cell Lymphoma • Hematological Malignancies • Indolent Lymphoma • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

KT-US-499-0150: Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma (clinicaltrials.gov) - P1/2 | N=25 | Active, not recruiting | Sponsor: Kite, A Gilead Company | Recruiting ➔ Active, not recruiting | N=14 ➔ 25 | Active, not recruiting ➔ Recruiting

Enrollment change • Enrollment closed • Enrollment open • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CSF2 • CXCL8 • IL15 • IL1R1 • IL7

KT-US-499-0150: Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma (clinicaltrials.gov) - P1/2 | N=247 | Recruiting | Sponsor: Kite, A Gilead Company | Trial completion date: Oct 2027 ➔ Feb 2030 | Trial primary completion date: Oct 2027 ➔ Feb 2030

Trial completion date • Trial primary completion date • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CSF2 • CXCL8 • IL15 • IL1R1 • IL7

Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy (clinicaltrials.gov) - P3 | N=550 | Not yet recruiting | Sponsor: Kite, A Gilead Company

New P3 trial • B Cell Lymphoma • Hematological Malignancies • Indolent Lymphoma • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Phase 1 Study of KITE-753 or KITE-363 in Patients with Relapsed/Refractory B-cell Lymphoma: Initial Safety and Preliminary Efficacy of KITE-753 and Updated Results of KITE-363 (TCT-ASTCT-CIBMTR 2026) - "Immune reconstitution was improved with KITE-363 compared to axicabtagene ciloleucel (axi-cel; Locke et al. To recognize how outcomes with KITE-753 and KITE-363 compare with available single-target CAR T- cell therapies 3 . To identify how the manufacturing process and design of these new therapies may contribute to an improved product phenotype and outcomes"

Clinical • P1 data • B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma

KT-US-499-0150: Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma (clinicaltrials.gov) - P1/2 | N=247 | Recruiting | Sponsor: Kite, A Gilead Company | Phase classification: P1 ➔ P1/2 | N=114 ➔ 247

Enrollment change • Phase classification • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CSF2 • CXCL8 • IL15 • IL1R1 • IL7

A Phase 1 study of KITE-753 or KITE-363 in patients with relapsed/refractory B-cell lymphoma: Initial safety and preliminary efficacy of KITE-753 and updated results of KITE-363 (ASH 2025) - "Amongall treated patients (N=37), 9 died (8 due to progression).Lymphodepletion was reduced and immune reconstitution was improved with KITE-363 compared toaxicabtagene ciloleucel (axi-cel; Locke FL, et al. KITE-363 results showed high response rates with encouraging durability in DL3 and amanageable safety profile. KITE-753's rapid manufacturing process preserving a juvenile productphenotype, in addition to its bicistronic CAR design with dual co-stimulation, was associated with lowincidence of CRS and ICANS, mostly Grade 1/2. The preliminary efficacy and safety profiles of KITE-753DL3 appeared promising; the expansion phase with DL3 in LBCL (n=17) is ongoing and will be presented."

Clinical • P1 data • B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Respiratory Diseases • Respiratory Syncytial Virus Infections

Initial Results from Kite-753, Optimized with Novel Manufacturing Process That Preserves T-Cell Fitness, Show High Complete Response Rate and Favorable Safety Trend (Gilead Press Release) - "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....Meanwhile, results for KITE-363 revealed that at a median follow-up of 17.5 months, there was a durable benefit at the highest dose level (2×106 CAR T cells/kg) among CAR-naïve patients, with more than 70% of complete responders evaluable at 12 months remaining in remission."

P1 data • Large B Cell Lymphoma

KITE-753: An Autologous Rapid Manufactured Anti-CD19/CD20 CAR-T Product for the Treatment of B-Cell Malignancies (ASH 2024) - P1 | "Hence, a Phase 1, first-in-human, open-label, multicenter study is currently ongoing to evaluate the safety and efficacy of KITE-363, a dual-targeting anti-CD19/CD20 CAR T-cell therapy, for the treatment of patients with relapsed/refractory B-cell lymphomas (NCT04989803). In addition to the potential to prevent and rescue CD19 negative relapses, the improved product potency of the rapid manufactured KITE-753 may enable the use of lower CAR-T doses in the clinic. A Phase 1, first-in-human, open-label, multicenter study is currently ongoing to evaluate the safety and efficacy of KITE-753 in patients with relapsed/refractory B-cell lymphomas (NCT04989803)."

IO biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Gilead and Kite Showcase Continued Progress in Transforming Blood Cancer Care With New Cell Therapy Data at ASH 2025 (Businesswire) - "Updated Results from Phase 2 Pivotal iMMagine-1 Study of Anito-cel for Relapsed/Refractory Multiple Myeloma to be Presented Orally...Kite will also share new data on its next-generation bicistronic autologous CAR T-cell therapies, KITE-363 and KITE-753...A key presentation for Yescarta (axicabtagene ciloleucel) includes a joint analysis of 4-year follow-up data from ZUMA-7, which evaluated Yescarta as a second-line therapy in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) eligible for autologous stem-cell transplant (ASCT), alongside 2-year follow-up data from ALYCANTE that evaluated patients who were ASCT ineligible."

Clinical data • Acute Lymphocytic Leukemia • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Large B Cell Lymphoma • Mantle Cell Lymphoma • Multiple Myeloma

KT-US-499-0150: Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma (clinicaltrials.gov) - P1 | N=114 | Recruiting | Sponsor: Kite, A Gilead Company | Trial completion date: May 2027 ➔ Oct 2027 | Trial primary completion date: May 2027 ➔ Oct 2027

Trial completion date • Trial primary completion date • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CSF2 • CXCL8 • IL15 • IL1R1 • IL7

KT-US-499-0150: Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma (clinicaltrials.gov) - P1 | N=114 | Recruiting | Sponsor: Kite, A Gilead Company | Trial primary completion date: Jul 2026 ➔ May 2027 | Trial completion date: Jul 2026 ➔ May 2027

Trial completion date • Trial primary completion date • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CSF2 • CXCL8 • IL15 • IL1R1 • IL7

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells (clinicaltrials.gov) - P=N/A | N=1000 | Enrolling by invitation | Sponsor: Kite, A Gilead Company | N=700 ➔ 1000

Enrollment change • Hematological Disorders • Hematological Malignancies • Oncology

Kite to Highlight Industry-Leading CAR T-Cell Therapy Portfolio at ASH 2024… (Businesswire) - "Advancements in Kite’s pipeline will...be highlighted, including data presented on Kite’s next generation CAR T-cell therapy KITE-753, an autologous anti-CD19/CD20 CAR T-cell therapy for the treatment of B-cell malignancies."

P1 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

KT-US-499-0150: Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma (clinicaltrials.gov) - P1 | N=114 | Recruiting | Sponsor: Kite, A Gilead Company | Trial completion date: Jan 2027 ➔ Jul 2026 | Trial primary completion date: Jul 2025 ➔ Jul 2026

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

KT-US-499-0150: Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma (clinicaltrials.gov) - P1 | N=114 | Recruiting | Sponsor: Kite, A Gilead Company | Trial completion date: Jan 2041 ➔ Jan 2027 | Trial primary completion date: Apr 2024 ➔ Jul 2025

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology