Safety study testing ADI-001 in adults with various autoimmune diseases
by Margarida Maia, PhD | March 18, 2025

Adicet Bio expects adults with systemic sclerosis (SSc) soon to start enrolling in its ongoing Phase 1 clinical trial of ADI-001, an experimental CAR T-cell therapy that the company is developing for a number of autoimmune diseases.

The company had expected sites to open to SSc patients before the end of last year, and now anticipates recruitment to be underway by the close of June. The open-label Phase 1 clinical trial (NCT06375993) currently is continuing to enroll adults with lupus nephritis, a common complication of the autoimmune disease lupus.

Depending on the speed with which people with SSc are enrolled, preliminary data on treated patients might be available toward the close of 2025.

ADI-001 targets B-cells, aiming to prevent damaging immune system attacks
ADI-001 recently received fast track status in the U.S. for treating adults with SSc, which works to speed the development and review of therapies for serious diseases with an unmet need.

This designation “highlights the significant unmet need for innovative, off-the-shelf therapies to treat autoimmune diseases,” Chen Schor, president and CEO of Adicet Bio, said in a company press release reporting on last year’s financial results and recent progress.

Systemic sclerosis, also called systemic scleroderma, is a multisystem autoimmune disease marked by the accumulation of scar tissue in the skin and organs that can include the heart, kidneys, lungs, and digestive tract.

Autoimmune diseases like SSc occur when the immune system produces antibodies that mistakenly react against healthy tissues in the body, guiding a damaging immune attack. Antibodies, including self-reactive ones, are produced by immune B-cells.

ADI-001 involves collecting a patient’s immune T-cells and modifying them in the lab before returning them via an infusion. T-cells are modified such that they produce a chimeric antigen receptor, or CAR, that binds to CD20, a protein found on the surface of B-cells.

Most of the T-cells present in ADI-001 are of a subtype called gamma delta T-cells, which naturally target various tissues, according to the company. Once CAR T-cells bind to CD20, they are activated to destroy B-cells, as reported in early clinical data from people with B-cell cancers, another indication for which the therapy is being developed.
​
By killing B-cells, ADI-001 is expected to reduce the production of self-reactive antibodies, easing symptoms in people with autoimmune diseases.

Patients also had abnormal levels of heart damage marker BNP, uric acid
by Andrea Lobo, PhD | March 4, 2025

Low levels of a type of white blood cell called natural killer (NK) cells may help diagnose pulmonary arterial hypertension (PAH) in people with systemic sclerosis (SSc), a study in China suggests.

In PAH, the blood vessels that supply blood to the lungs, called pulmonary arteries, narrow, restricting blood flow and raising blood pressure. In the study, about 28% of the SSc patients had PAH.

Abnormal levels of BNP, a marker of heart damage, and of uric acid, which is an indicator of lower kidney function, were also evident in SSc-PAH patients.

“These indicators can aid in evaluating disease activity and pulmonary hypertension incidence in SSc,” wrote the researchers, who noted that while the markers have “clinical value for diagnosing PAH … their independent diagnostic utility for SSc-PAH remains suboptimal.” The study, “Natural killer cells are decreased in systemic sclerosis and have diagnostic value for pulmonary arterial hypertension incorporation,” was published in Scientific Reports.

SSc is marked by inflammation and fibrosis, or the accumulation of scar tissue, in the skin and even the internal organs, including the lungs. PAH is a leading cause of death in SSc, also called scleroderma.
​
The disease mechanisms involve autoimmune, or self-reactive, processes and abnormal inflammatory responses. Immune NK cells have been implicated in other autoimmune diseases and have shown alterations in people with SSc.

Acid reflux, depression symptoms also contributed to poor experience by Patricia Inácio, PhD | February 25, 2025

​People with systemic sclerosis (SSc) face significantly worse sleep quality than those with rheumatoid arthritis (RA) and healthy people, a study reports.
Poor sleep hygiene and clinical factors, including gastroesophageal reflux disease, that is, acid reflux, and depression-like symptoms, were key contributors.

These findings highlight how “enhancing sleep hygiene practices may serve as a crucial strategy to improve the overall sleep quality in SSc,” the researchers wrote. The study, “Inadequate sleep hygiene as a key factor in poor sleep quality in systemic sclerosis: an observational, cross-sectional study,” was published in Rheumatology International.

In SSc, also called scleroderma, scar tissue accumulates in the skin and also can in internal organs, including the heart, kidneys, lungs, and digestive tract. Sleep impairments are known to be high among people with SSc and RA, also an autoimmune disorder.

Here, researchers in Turkey evaluated how sleep hygiene — the collection of lifestyle, environmental, and behavioral strategies for healthy sleep habits — influences sleep quality and correlates with clinical parameters in SSc patients.

​They also compared sleep hygiene and sleep quality between people with SSc, those with RA, and healthy people, who served as controls. Each group was composed of 70 age-matched participants, all female. The median age in the SSc group was 52.7.

Staying aware of my body and the signals it may be giving me is crucial by Tomisa Starr | February 19, 2025

As we get older, how can we tell the difference between the effects of aging and the symptoms and comorbidities related to scleroderma?

When most people think of scleroderma, aging with the disease doesn’t immediately come to mind. When I first read about it in 1974, patients with the disease had far fewer treatment options than they do today. That’s changed, thankfully, and we’re now likely to survive for a longer time.

My diagnosis came when I was a 30-year-old wife and mother. My rheumatologist told me the disease could affect every organ in the body, and she was concerned that my case seemed to be progressing fast. Beyond the physical, it’s not uncommon for people to experience fear and anxiety with any serious illness, and I did.
​
But over 30 years later, here I am, a senior citizen with scleroderma.