ImmPACT Bio has secured an $8m grant from the California Institute for Regenerative Medicine (CIRM) for its Phase Ib/II clinical trial of IMPT-514 to treat refractory lupus nephritis (LN) and systemic lupus erythematosus (SLE).

A CD19/CD20-targeting bispecific chimeric antigen receptor (CAR) T-cell therapy, IMPT-514, is designed for autoreactive immune cell depletion.

The open-label dose escalation trial is designed to enrol participants with active, refractory SLE that was priorly treated with a minimum of two standard-of-care therapies previously.

Furthermore, these subjects should have a SLE Disease Activity Index score (SLEDAI-2K) greater than eight to be eligible for the trial.

The Phase I dose escalation segment specifically targets subjects who have active, biopsy-proven, proliferative LN.

During the subsequent Phase II portion of the clinical trial, additional patients, both with and without active proliferative LN, will be enrolled.

IMPT-514 was effectively produced from heavily immunosuppressed patients with LN and SLE in preclinical studies.

The therapy also demonstrated potent removal of autologous B cells and a moderate cytokine profile.

The US Food and Drug Administration (FDA) previously granted fast-track designation for the IMPT-514 treatment in active and refractory LN and SLE.

Notably, IMPT-514 shares the same CAR construct as another company asset, IMPT-314.

IMPT-314 is under development for certain types of non-Hodgkin’s lymphoma.

ImmPACT Bio chief medical officer Jonathan Benjamin said: “There is a critical unmet medical need for well-tolerated therapies that offer improved efficacy and durable disease remission.

“Based on the promising responses and a favourable safety profile observed in the UCLA trial in non-Hodgkin lymphoma, we are encouraged that IMPT-514 has the potential to alleviate symptoms and spare patients the need for chronic immune suppression.

“We expect initial efficacy and safety data from our Phase Ib/II dose escalation trial in the second half of 2024.”