Eque-cel T-Cell Therapy Receives IND Approval for Treatment of SLE, Lupus Nephritis

The US Food and Drug Administration (FDA) approved the Investigational New Drug (IND) application for equecabtagene autoleucel (Eque-cel) for the treatment of nonrenal systemic lupus erythematosus (SLE) and lupus nephritis (LN). With this clearance, the drug can now be administered in human trials.

Eque-cel is a fully human anti–B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) autologous T-cell therapy manufactured by IASO Biotherapeutics. According to the manufacturers, Eque-cel utilizes “second-generation CAR technology to precisely identify and eliminate cells expressing BCMA.”

“We are delighted that the IND for the 2 new indications—SLE and LN—has been approved by the FDA, further highlighting [the potential of Eque-cel] as a product for autoimmune diseases,” said Yongke Zhang, MD, chief scientific officer of IASO Biotherapeutics, in a press release. “Clinical trial data from China have demonstrated [the significant efficacy and safety of Eque-cel] in treating relapsed or refractory autoantibody-mediated neurological diseases. We believe it holds similar promise for other autoimmune diseases, such as SLE and LN, where autoantibodies play key pathogenic roles.”

This is the third IND approval from the FDA for Eque-cel to treat autoimmune diseases. The CAR T-cell therapy also received an IND approval for treatment of myasthenia gravis and multiple sclerosis. In China, Eque-cel has received 2 IND approvals: for treatment of neuromyelitis optica spectrum disorder and myasthenia gravis.