2023-03-31 07:19:46 ET
The U.S. Food and Drug Administration (FDA) cleared Cabaletta Bio's ( NASDAQ: CABA ) investigational new drug (IND) application seeking to start a trial of lupus therapy CABA-201.
The company plans to begin a phase 1/2 trial of CABA-201 to treat systemic lupus erythematosus (SLE) in patients with active lupus nephritis (LN) or active SLE without renal involvement.
SLE is an autoimmune disorder in which the immune system attacks its own tissues causing inflammation and tissue damage. The condition can affect skin, brain, lungs, kidneys, blood vessels and joints.
CABA-201 — a fully human CD19-CAR T cell therapy — is to be given as a one-time infusion, with the potential to eliminate B cells, thus helping an "immune system reset" and durable remission in patients with SLE, the company added.
"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," said Cabaletta Co-Founder and CEO Steven Nichtberger.
The company expects to report 3-month data by H1 2024.
For further details see:
Cabaletta CAR T cell therapy for lupus gets FDA nod to enter trial