SOUTH SAN FRANCISCO, CA, USA I July 24, 2024 I Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, today announced that researchers at Columbia University Irving Medical Center (CUIMC) have initiated an investigator-sponsored trial (“IST”) of NKX019, Nkarta’s allogeneic, CD19-directed chimeric antigen receptor (CAR) NK-cell therapy in patients with systemic lupus erythematosus (SLE). The IST broadens the clinical evaluation of NKX019 in lupus. In June 2024, Nkarta announced the initiation of Ntrust-1, its Phase 1 clinical trial of NKX019 in patients with lupus nephritis (LN).
The single-center, single-arm, open-label Phase 1 IST is being led by Anca D. Askanase, M.D., M.P.H., Director, Lupus Center at CUIMC and the Director of Rheumatology Clinical Trials.
“People with lupus face significant challenges, including years of exposure to toxic/partially effective medications,” said Dr. Askanase. “Cell therapy provides the hope of long-term, medication-free remission.”
The CUIMC IST is designed to enroll up to 6 patients with SLE, regardless of renal involvement, and will evaluate safety and clinical outcomes in a potentially different population than Ntrust-1. Translational and biomarker studies, including autoantibodies, cytokine profiles and pharmacokinetics are also planned. Patients receive NKX019 on Days 0, 7 and 14 following single-agent lymphodepletion with cyclophosphamide. Patient screening is underway.
Systemic lupus erythematosus (SLE) is an autoimmune disease that causes the body’s immune system to attack its own tissues. The dysregulated immune system produces antibodies that can affect various organs, including the skin, joints, kidneys, heart, and brain. Symptoms can include fatigue, joint pain, or severe life-threatening organ disease. SLE can cause lupus nephritis (LN), a severe complication that affects the kidneys.
“With its reduced-toxicity lymphodepletion regimen, enabled by cytokine engineering, we believe that NKX019 has potential to reach more patients, including those with less advanced disease,” said David R. Shook, M.D., Nkarta’s Chief Medical Officer and Head of R&D. “We’re eager to collaborate with our academic partners at Columbia and look forward to making a difference in the lives of people living with autoimmune diseases like lupus.”
About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed chimeric antigen receptor (CAR) for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease and B cell-derived malignancies.
About Nkarta
Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf, on-demand natural killer (NK) cell therapies. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies and CRISPR-based genome engineering capabilities, Nkarta is building a pipeline of future cell therapies engineered for deep therapeutic activity and intended for broad access in the outpatient treatment setting. For more information, please visit the company’s website at www.nkartatx.com.
SOURCE: Nkarta
Post Views: 4,311
SOUTH SAN FRANCISCO, CA, USA I July 24, 2024 I Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, today announced that researchers at Columbia University Irving Medical Center (CUIMC) have initiated an investigator-sponsored trial (“IST”) of NKX019, Nkarta’s allogeneic, CD19-directed chimeric antigen receptor (CAR) NK-cell therapy in patients with systemic lupus erythematosus (SLE). The IST broadens the clinical evaluation of NKX019 in lupus. In June 2024, Nkarta announced the initiation of Ntrust-1, its Phase 1 clinical trial of NKX019 in patients with lupus nephritis (LN).
The single-center, single-arm, open-label Phase 1 IST is being led by Anca D. Askanase, M.D., M.P.H., Director, Lupus Center at CUIMC and the Director of Rheumatology Clinical Trials.
“People with lupus face significant challenges, including years of exposure to toxic/partially effective medications,” said Dr. Askanase. “Cell therapy provides the hope of long-term, medication-free remission.”
The CUIMC IST is designed to enroll up to 6 patients with SLE, regardless of renal involvement, and will evaluate safety and clinical outcomes in a potentially different population than Ntrust-1. Translational and biomarker studies, including autoantibodies, cytokine profiles and pharmacokinetics are also planned. Patients receive NKX019 on Days 0, 7 and 14 following single-agent lymphodepletion with cyclophosphamide. Patient screening is underway.
Systemic lupus erythematosus (SLE) is an autoimmune disease that causes the body’s immune system to attack its own tissues. The dysregulated immune system produces antibodies that can affect various organs, including the skin, joints, kidneys, heart, and brain. Symptoms can include fatigue, joint pain, or severe life-threatening organ disease. SLE can cause lupus nephritis (LN), a severe complication that affects the kidneys.
“With its reduced-toxicity lymphodepletion regimen, enabled by cytokine engineering, we believe that NKX019 has potential to reach more patients, including those with less advanced disease,” said David R. Shook, M.D., Nkarta’s Chief Medical Officer and Head of R&D. “We’re eager to collaborate with our academic partners at Columbia and look forward to making a difference in the lives of people living with autoimmune diseases like lupus.”
About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed chimeric antigen receptor (CAR) for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease and B cell-derived malignancies.
About Nkarta
Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf, on-demand natural killer (NK) cell therapies. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies and CRISPR-based genome engineering capabilities, Nkarta is building a pipeline of future cell therapies engineered for deep therapeutic activity and intended for broad access in the outpatient treatment setting. For more information, please visit the company’s website at www.nkartatx.com.
SOURCE: Nkarta
Post Views: 4,311
