Off-the-shelf CAR T therapy shows potential for lupus remission; Adicet reports early clinical results

Adicet Bio’s “off-the-shelf” CAR T therapy showed potential to bring lupus into remission.

According to BioPharma Dive on the 28th (local time), Adicet Bio said its gamma delta cell therapy outperformed previous results with personalized CAR T therapies in an early-stage clinical trial.

In an early-stage clinical trial in patients with lupus nephritis, results after 1 year of follow-up showed that 50% of evaluable patients had a “complete” renal response to treatment, while 54% met remission criteria under a widely used statistical standard.

All of these patients had previously tried several other treatments and stopped taking immunosuppressants after treatment.

Adicet said there were no cases of severe cytokine release syndrome (CRS) or neurologic adverse events, which are considered major side effects of cell therapy.

However, about one-quarter of patients who received treatment experienced mild or moderate CRS, and infections were reported in more than half. About 8% of the infections were classified as grade 3 or higher.

The company’s therapy, “prula-cel,” is an allogeneic approach derived from donor cells, allowing for faster and less expensive manufacturing. Gamma delta T cells, the basis of prula-cel, differ from the alpha beta T cells used by Novartis and Bristol Myers Squibb, among others.

In an email to BioPharma Dive, Chen Shore, Adicet’s CEO, explained that gamma delta cells “secrete fewer inflammatory cytokines, and at lower levels,” which can cause immune-related adverse events.

Jefferies analyst Dennis Ding said the efficacy data were “competitive with cell therapies and antibody therapies.” Competing cell therapy developers have reported complete response rates of about 40%.

Ding called the data “impressive” and added that they “could encourage pharmaceutical companies to begin moving toward more sophisticated approaches, such as gamma delta T cells, in treating immune diseases.”

“What is most exciting is the opportunity to change the standard of care for patients with lupus from lifelong chronic immunosuppressant and steroid treatment,” Shore said.

Adicet plans to start a confirmatory trial in lupus in the fourth quarter and will also discuss with regulators the possibility of expanding trials to patients without lupus nephritis.

Meanwhile, Adicet shares fell 22% on the morning of the same day. The company’s valuation has declined since peaking in 2022, when its gamma delta CAR T therapy showed potential in cancer.