FDA clears way for trial of novel bispecific T-cell engager for lupus
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The FDA has cleared an investigational new drug application allowing a novel bispecific T-cell engager to begin a phase 1 trial in patients with active, moderate-to-severe systemic lupus erythematosus, according to a press release.
“There remains a significant unmet medical need among patients with systemic lupus erythematosus, as current therapies often fail to fully control disease activity and prevent long-term organ damage,” Jeffrey Jones, MD, MBA, chief medical officer at Cullinan Therapies, said in a company press release. “CLN-978, our novel bispecific T-cell engager, targets CD19, offering a highly differentiated approach to deliver the potency of T cell redirecting therapy with off-the-shelf access and convenient dosing through subcutaneous administration.”
According to the manufacturer, CLN-978 works by triggering redirected lysis of CD19-expressing target cells. It has two single-chain variable fragments, one that binds with high affinity to CD19 on B cells and one that binds to CD3 on T cells, and its serum half-life is lengthened by a single-domain antibody that binds to human serum albumin.
The planned clinical trial will evaluate the drug’s safety for the treatment of moderate-to-severe SLE, with pharmacokinetics, B cell kinetics, immunogenicity and clinical activity as secondary outcomes. The trial will include participants whose SLE Disease Activity Index score is eight or higher, with inadequate response to at least two treatments, including an immunosuppressive or biologic standard-of-care therapy.
The first part of the trial will involve dose escalation to find a target dose, starting at 10 micrograms. The results will inform the second part, which will consist of dose expansion and exploration of multiple dosages.
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