Cabaletta Bio to Commence Trial of CABA-201 for Lupus Treatment After FDA Clearance
Cabaletta Bio, a clinical-stage biotechnology company, is to launch a Phase I/II clinical trial of CABA-201 to treat systemic lupus erythematosus (SLE) in patients suffering from active lupus nephritis (LN) or active SLE without renal involvement.
Cabaletta has focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, after securing approval from the FDA for its investigational new drug application for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy.
CABA-201 will be investigated in a Phase I/II open-label dose evaluation study in patients with SLE, with either active LN or active SLE without renal involvement. Patients are to receive a standard preconditioning regime of fludarabine and cyclophosphamide before CABA-201 administration.
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The clearance has been given within six months of in-licensing the CABA-201 binder.
SLE is a chronic, potentially severe, autoimmune disease that usually affects young women between the age group of 15 and 40, with more severity in people of color. It is characterized by abnormal B cell function and autoantibody production.
“We believe the clearance of this IND application within 6 months of licensing the binder for CABA-201 is an important milestone for patients with autoimmune disease,” informs Steven Nichtberger, M.D., CEO and Co-founder of Cabaletta. “By achieving a timely IND clearance, we believe we are well positioned to generate 3-month clinical data on efficacy endpoints and tolerability for patients dosed with CABA-201 by the first half of 2024,” he adds.
Nichtberger believes CABA-201 has the potential a ‘durable response’ for patients with SLE and possibly other autoimmune diseases.
CABA-201 is designed to be a one-time infusion with the intention of potentially eliminating B cells enabling an ‘immune system reset’ with durable remission in patients with SLE.
Source: Cabaletta Bio Press Release
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