KITE-222 / Gilead, Kite Pharma - LARVOL DELTA

Phase 1 Study of KITE-222, an Autologous CLL-1-directed CAR T-cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia. (PubMed, Clin Cancer Res) - "Despite successful manufacturing and acceptable safety, KITE-222 lacked preliminary efficacy, warranting future studies that address CLL-1 heterogeneity and focus on improving in vivo expansion and antitumor activity."

Journal • P1 data • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Neutropenia • Oncology • Thrombocytopenia

Study of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=15 | Terminated | Sponsor: Kite, A Gilead Company | N=40 ➔ 15 | Trial completion date: Feb 2026 ➔ May 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Feb 2026 ➔ May 2024; Study was terminated due to futility

CAR T-Cell Therapy • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Study of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: Kite, A Gilead Company | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2039 ➔ Feb 2026 | Trial primary completion date: Oct 2024 ➔ Feb 2026

CAR T-Cell Therapy • Enrollment closed • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • 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

Study of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Kite, A Gilead Company | Trial primary completion date: Jan 2024 ➔ Oct 2024

CAR T-Cell Therapy • Trial primary completion date • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • 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: Nov 2026 ➔ Mar 2041 | Trial primary completion date: Nov 2026 ➔ Mar 2041

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

FDA grants orphan drug designation to CAR-T for acute myeloid leukemia (Healio) - "The FDA granted orphan drug designation to KITE-222, an investigational chimeric antigen receptor T-cell therapy, for treatment of adults with relapsed or refractory acute myeloid leukemia. KITE-222 (Kite Pharma/Gilead Sciences) - an autologous, gene-edited CAR T-cell therapy - targets C-type lectin-like molecule-1 (CLL-1), which is expressed by lineage-committed myeloid cells and absent on healthy hematopoietic stem cells."

Orphan drug • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Study Evaluating the Safety of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Gilead Sciences; Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Clinical • Enrollment open • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Study Evaluating the Safety of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Gilead Sciences

CAR T-Cell Therapy • Clinical • New P1 trial • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology