Cabaletta Bio is set to commence 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.

The company’s decision comes after it secured approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy.

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.

In the proposed open label dose evaluation trial, patients will receive a standard preconditioning regimen comprising fludarabine and cyclophosphamide before CABA-201 infusion.

It will be the first trial to use Cabaletta’s Chimeric Antigen Receptor T cells for Autoimmunity (CARTA) strategy, said the firm.

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Cabaletta Bio CEO and co-founder Steven Nichtberger said: “Based on its similarity to the product used in the Nature Medicine paper, we believe CABA-201 has the potential to provide deep and durable responses for patients with SLE, and possibly other autoimmune diseases where B cells play a role to initiate or sustain disease pathology.

“By achieving a timely IND clearance, we believe we are well positioned to generate three-month clinical data on efficacy endpoints and tolerability for patients dosed with CABA-201 by the first half of 2024.”

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