KITE-363 / Gilead - LARVOL DELTA

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

A Phase 1 Open-label, Multiregional, Multicenter, BasketnStudy Evaluating the Safety and Efficacy of KITE-363, annAutologous Anti-CD19/CD20 CAR T-cell Therapy innParticipants with Relapsed/Refractory AutoimmunenNeurologic Diseases (ANZCTR) - P1 | N=52 | Not yet recruiting | Sponsor: Kite, A Gilead Company

New P1 trial • CNS Disorders • Immunology • Multiple Sclerosis • Myasthenia Gravis • Pain

Phase 1 Open-Label Basket Study of KITE-363 Anti-CD19/CD20 Chimeric Antigen Receptor (CAR) T-Cell Therapy in Patients with Refractory Autoimmune Diseases (KIDNEY WEEK 2025) - P1 | "Lymphodepleting chemotherapy (fludarabine/cyclophosphamide) will be administered followed by a single KITE-363 infusion. The study is open and recruiting patients (NCT07038447). LC and DF contributed equally."

Clinical • P1 data • Pan tumor • B Cell Lymphoma • Glomerulonephritis • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Lymphoma • Myositis • Nephrology • Non-Hodgkin’s Lymphoma • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

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

KITE-363: An Autologous Anti-CD19/CD20 CAR-T Product for the Treatment of Autoimmune Rheumatic Diseases (ACR Convergence 2025) - "Highly variable expression of CD19 and/or CD20 in B cell subsets, jointly with antigen-specific and B-cell depleting activity of KITE-363, support clinical development of KITE-363 in B cell-mediated auto-immune conditions. With dual-antigen targeting and optimized co-stimulation, KITE-363 has the potential to induce a more comprehensive B-cell depletion and achieve durable, drug-free remission in these diseases. A Phase 1 open-label, multicenter study is underway to evaluate the safety and efficacy of KITE-363 in participants with refractory autoimmune rheumatic diseases."

IO biomarker • B Cell Lymphoma • Glomerulonephritis • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Lymphoma • Myositis • Nephrology • Non-Hodgkin’s Lymphoma • Rheumatology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • CD19 • CD27

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

A Study of KITE-363 in Participants With Refractory Autoimmune Diseases (clinicaltrials.gov) - P1 | N=52 | Enrolling by invitation | Sponsor: Kite, A Gilead Company | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myositis • Nephrology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

A PHASE 1 STUDY OF KITE-363 ANTI-CD19/CD20 CHIMERIC ANTIGEN RECEPTOR (CAR) T-CELL THERAPY IN PATIENTS WITH RELAPSED/REFRACTORY (R/R) B-CELL LYMPHOMA (ICML 2025) - "No dose-limiting toxicities occurred in Phase 1A. The safety profile of KITE-363 was tolerable, with no Grade ≥ 3 CRS in patients with LBCL and 2 cases of Grade 3 ICANS at the highest DL. KITE-363 demonstrated high responses in patients with highly refractory B-cell lymphoma, including those with primary refractory disease."

Clinical • P1 data • B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Indolent Lymphoma • Large B Cell Lymphoma • Lymphoma • Myelodysplastic Syndrome • Nodular Lymphocyte Predominant Hodgkin Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

A PHASE 1 STUDY OF KITE-363 ANTI-CD19/CD20 CHIMERIC ANTIGEN RECEPTOR T-CELL THERAPY IN PATIENTS WITH RELAPSED/REFRACTORY B-CELL LYMPHOMA (EHA 2025) - "No dose-limiting toxicities occurred in Phase 1A. The safety profile of KITE-363 was tolerable with no Grade ≥3 CRS in patients with LBCL and cases of Grade 3 ICANS at the highest dose level. KITE-363 demonstrated high responses in patients with highly refractory B-cell lymphoma including those with primary refractory disease."

CAR T-Cell Therapy • Clinical • P1 data • B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Indolent Lymphoma • Large B Cell Lymphoma • Lymphoma • Myelodysplastic Syndrome • Nodular Lymphocyte Predominant Hodgkin Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of KITE-363 in Participants With Refractory Autoimmune Diseases (clinicaltrials.gov) - P1 | N=52 | Not yet recruiting | Sponsor: Kite, A Gilead Company

New P1 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myositis • Nephrology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

A phase 1 study of KITE-363 anti-CD19/CD20 chimeric antigen receptor (CAR) T-cell therapy in patients (pts) with relapsed/refractory (R/R) B-cell lymphoma (BCL). (ASCO 2025) - P1 | "No DLTs occurred in Phase 1A. Safety profile of KITE-363 was tolerable, with no Grade ≥3 CRS in pts with LBCL and 2 cases of Grade 3 ICANS at the highest DL. KITE-363 demonstrated high responses in pts with highly refractory BCL, including those with primary refractory disease."

Clinical • P1 data • B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Indolent Lymphoma • Lymphoma • Myelodysplastic Syndrome • Nodular Lymphocyte Predominant Hodgkin Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

KITE-363 Elicits Responses With Acceptable Tolerability in R/R B-Cell Lymphoma (OncLive) - P1 | N=114 | NCT04989803 | Sponsor: Kite, A Gilead Company | "Safety data indicated that no dose-limiting toxicities (DLTs) were reported in phase 1a. Grade 3 or higher adverse effects (AEs) were experienced by 2 patients who received the agent at dose level 1 (DL1; n = 3), which was 0.5 x 106 CAR T cells/kg. Grade 3 or higher AEs were reported in 6 patients who received dose level 2 (DL2; n = 8), which was 1 x 106 CAR T cells/kg. In those who received dose level 3 (DL3; n = 26), which was 2 x 106 CAR T cells/kg, the most common grade 3 or higher AEs included decreased white blood cell (WBC) count (n = 11), neutropenia (n = 8), and decreased neutrophil count (n = 11)."

P1 data • B Cell Non-Hodgkin 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 | 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

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells (clinicaltrials.gov) - P2 | N=700 | Enrolling by invitation | Sponsor: Kite, A Gilead Company | Trial completion date: Mar 2041 ➔ Dec 2040 | Trial primary completion date: Mar 2041 ➔ Dec 2040

Trial completion date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • 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

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 | N=80 ➔ 114

CAR T-Cell Therapy • Enrollment change • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CCL2 • CRP • CSF2 • CXCL10 • CXCL8 • GZMA • GZMB • IFNG • IL10 • IL15 • IL17A • IL1R1 • IL2 • IL2RA • IL6 • IL7 • TNFA

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells (clinicaltrials.gov) - P2 | N=700 | Enrolling by invitation | Sponsor: Kite, A Gilead Company | Trial completion date: Nov 2026 ➔ Mar 2041 | Trial primary completion date: Nov 2026 ➔ Mar 2041

Trial completion date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Oncology

KITE-363: A phase 1 study of an autologous anti-CD19/CD20 chimeric antigen receptor (CAR) T-cell therapy in patients with relapsed/refractory (R/R) B-cell lymphoma (BCL). (ASCO 2022) - P1 | "Patients will then receive conditioning chemotherapy (cyclophosphamide and fludarabine) on Day ‒5 to Day ‒3 followed by KITE-363 infusion on Day 0. Key exclusion criteria are central nervous system (CNS) involvement from lymphoma, active infection including hepatitis B and C, and clinically significant CNS disorder. This study is currently open and accruing patients."

Clinical • P1 data • CNS Disorders • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Hepatitis B • Hepatology • Hodgkin Lymphoma • Indolent Lymphoma • Infectious Disease • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD20 • CD28

Study Evaluating the Safety and Efficacy of KITE-363 in Participants With Relapsed and/or Refractory B-cell Lymphoma (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Kite, A Gilead Company | Trial primary completion date: Jan 2026 ➔ Feb 2024

CAR T-Cell Therapy • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CCL2 • CRP • CSF2 • CXCL10 • CXCL8 • GZMA • GZMB • IFNG • IL10 • IL15 • IL17A • IL1R1 • IL2 • IL2RA • IL6 • IL7 • TNFA

Study Evaluating the Safety and Efficacy of KITE-363 in Participants With Relapsed and/or Refractory B-cell Lymphoma (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: Kite, A Gilead Company; Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Clinical • Enrollment open • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CCL2 • CRP • CSF2 • CXCL10 • CXCL8 • GZMA • GZMB • IFNG • IL10 • IL15 • IL17A • IL1R1 • IL2 • IL2RA • IL6 • IL7 • TNFA