Adicet Bio Reports Lupus Remissions in CAR-T Trial, Avoiding Safety Issues Seen in Rivals

Key points

• In a Phase 1 trial, 54% of patients achieved remission of systemic lupus erythematosus (SLE) and 50% of those with lupus nephritis achieved complete renal response at 12 months.
• The therapy, which uses gamma delta T cells, resulted in no cases of immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) or neurotoxicity syndrome (ICANS), unlike recent issues with Novartis and BMS programs.
• All patients discontinued immunosuppressants, and all but one reduced steroids to 5 mg or less, indicating a potential 'one-and-done' treatment model.
• Adicet plans to start a pivotal trial for lupus nephritis in the fourth quarter of 2026, with potential expansion to non-renal lupus patients.
• Analysts, including Wedbush, raised price targets on Adicet Bio stock following the data release, citing the favorable safety and efficacy profile.

Background

This development follows a period of safety concerns in the autoimmune CAR-T space. In early September 2026, Novartis and Bristol Myers Squibb paused their respective CD19-targeted CAR-T trials after reports of fatal IEC-HS events and inflammatory reactions. Additionally, earlier in August, a third death was reported in China's opaque CAR-T trials. Adicet's use of an off-the-shelf, gamma delta T-cell approach appears to mitigate these specific risks, offering a contrast to the autologous CD19 therapies that faced setbacks.

How outlets are covering it

Fierce Biotech emphasizes the 'immune reset' aspect, noting that new B cells are naive and not associated with disease, which CEO Chen Schor describes as a potential new era for autoimmune treatment. The Daily Tribune News highlights the regulatory alignment, noting the FDA's agreement to a single-arm pivotal trial and the potential for outpatient administration due to the safety profile. Investing.com focuses on the financial impact, reporting that Wedbush raised its price target to $28 and that the stock has surged 39% over six months, while Guggenheim adjusted its target to $90. All sources agree on the core efficacy data: 54% DORIS remission and 50% complete renal response, but differ in emphasis between clinical mechanism, regulatory pathway, and market valuation.

Why it matters

The success of prula-cel suggests that off-the-shelf, gamma delta T-cell CAR-T therapies may offer a safer alternative to autologous CD19-based treatments for autoimmune diseases. If the pivotal trial succeeds, it could provide a durable, single-dose cure for lupus, eliminating the need for chronic immunosuppression and reducing the risk of severe inflammatory side effects that have stalled competitors.

What to watch

Adicet Bio will initiate start-up activities for a pivotal study in lupus nephritis in the fourth quarter of 2026. The company plans to discuss with the FDA the potential expansion of this trial to include patients with non-renal lupus. A clinical data update for systemic sclerosis is expected in the first half of 2027, with further lupus data anticipated by mid-2027.