Jan Janisch-Hanzlik once feared her multiple sclerosis would confine her to a wheelchair. The 49-year-old former nurse in Blair, Nebraska, had given up her active job for desk work. Falls worried her when she held her grandchildren. Standard medicines brought little relief.
So she called the University of Nebraska Medical Center every other month. She became the first patient there to receive an experimental CAR-T cell therapy originally developed for blood cancers. The treatment, given in June 2025, carried risks of dangerous inflammation. Yet hope won out. Her grandchildren, who face higher genetic odds of the disease, motivated her. “I would want to be able to say I did everything that I possibly could,” she told Ars Technica.
Months later, double vision vanished. She stopped needing her cane around the house. Naps that once stretched three hours daily became unnecessary. A trip to the Grand Canyon followed. Some symptoms linger – leg weakness, foot numbness, word-finding trouble. Still, she rarely falls now. “I definitely am thankful for every day I have,” she said.
Her story marks one early success in a surge of trials testing CAR-T against autoimmune diseases. What began as a cancer breakthrough now shows striking results in lupus, stiff person syndrome, myasthenia gravis, systemic sclerosis and multiple sclerosis. Remissions stretch months, sometimes years. Patients drop other drugs. Side effects often prove milder than in oncology.
But questions remain. How long do benefits last? Will rare long-term toxicities emerge? Can manufacturing scale to serve millions? Companies race to answer with new designs, off-the-shelf products and regulatory shortcuts.
From oncology roots to immune reset
CAR-T therapy extracts a patient’s T cells, engineers them to express a chimeric antigen receptor, then returns them. The receptor targets CD19 on B cells. In cancer, those B cells turn malignant. In autoimmunity, they produce antibodies that attack healthy tissue.
A German team first tried this approach in lupus in 2021. One patient achieved drug-free remission. Five years later, she remains well and works in the same clinic. That case, reported in the New England Journal of Medicine, sparked dozens of studies.
Since then, results have multiplied. In stiff person syndrome, Kyverna Therapeutics tested its therapy in 26 patients. Before treatment, many walked with mechanical gaits. Twelve needed walkers or canes. By 16 weeks, most moved faster. Eight ditched assistive devices for short distances. All 26 had stopped other immunotherapies four to 12 months later, the company said in an April 2026 press release.
A separate trial of Cartesian Therapeutics’ mRNA-based CAR-T involved 15 autoimmune patients. Two-thirds improved. None faced long-term serious side effects, according to a Nature Medicine paper.
Even more dramatic, one woman with three ultra-rare autoimmune diseases received CAR-T at University Hospital Erlangen in Germany. Fourteen months later, she reported no symptoms and took no medications. She had failed nine prior treatments and sometimes stayed bedridden for weeks. “Her disease got completely out of hand” and became “very life-threatening,” haematologist Fabian Müller told Nature.
These outcomes differ sharply from traditional care. Autoimmune patients often face lifelong immunosuppression. CAR-T offers a potential one-time reset. B cells plunge. The immune system rebuilds, sometimes sparing memory cells from past infections. Patients retain antibodies to chickenpox and measles in some cases.
Yet the process isn’t gentle. Chemotherapy clears space for the new cells. Temporary vulnerability to infections follows. Cytokine release syndrome and neurotoxicity can occur, though milder in autoimmune patients than in those with cancer. Physicians now manage these complications better after years of oncology experience. “They’re certainly reversible and don’t cause long-term damage most of the time,” rheumatologist Emily Littlejohn of the Cleveland Clinic told Ars Technica.
Longer-term worries persist. The FDA noted possible links to Parkinson’s-like symptoms and secondary T-cell cancers in cancer patients. Such risks may prove acceptable in oncology but demand scrutiny in chronic autoimmune conditions. Researchers watch closely.
And the cost? Hundreds of thousands of dollars per treatment, including manufacturing and hospital care. That limits access. Solutions loom. In-body engineering could skip the lab step. Allogeneic cells from healthy donors promise off-the-shelf options after gene edits prevent rejection.
Companies push forward. Kyverna started a rolling biologics license application for its stiff person syndrome therapy in May 2026, aiming for a 2027 approval. The FDA accepted single-arm trial data for this rare disease, a regulatory win that speeds the path. Bristol Myers Squibb accelerates Phase 3 work in scleroderma with faster five-day manufacturing.
Cartesian’s mRNA approach avoids permanent genetic changes. Cells lose targeting ability once mRNA fades. No long-term cancer risk from persistent modified cells. Infusions use higher cell numbers, potentially reducing inflammation. Early data look promising.
Recent regulatory nods add momentum. The FDA cleared an IND for Scripps Research’s switchable CAR-T targeting myositis, systemic sclerosis, lupus and rheumatoid arthritis. Trials will test safety and efficacy. Qihan Biotech gained clearance for an allogeneic dual-targeted product that skips harsh lymphodepletion. Allogene unveiled its Dagger platform candidate designed for similar conditioning-free use.
Academic groups expand too. UT MD Anderson and partners prepare trials that could extend to autoimmune indications. UNC’s James Howard leads Cartesian studies in myasthenia gravis. Early Phase 2b results showed 57% of patients reaching minimal symptom expression by month six, sustained to month 12.
Germany’s Miltenyi Biomedicine and Bristol Myers Squibb reported mild-to-moderate, self-resolving side effects in basket trials covering lupus, myositis, multiple sclerosis and more. No severe cytokine release or neurotoxicity stood out.
Still, not every patient responds perfectly. Janisch-Hanzlik’s lingering symptoms illustrate limits. Durability data stretch only so far. Some patients relapse after initial gains. Manufacturing bottlenecks threaten scale if demand explodes. Autologous approaches tie up capacity. Allogeneic and in vivo methods aim to break that constraint.
Investment floods in. STAT News reported a “flood of experimentation” five years after the first lupus success. STAT noted researchers once feared T cells might worsen autoimmunity. Instead, the opposite occurred.
Experts temper excitement with caution. Amanda Piquet, who led the Kyverna stiff person syndrome study at the University of Colorado, called the opportunity “perfect” for a condition with no approved therapies. Yet she and others stress the need for larger, longer trials.
Patient selection matters. Those with severe, refractory disease stand to gain most. Georg Schett, a pioneer in the field, shared tips on choosing candidates at recent meetings. Australian centers have treated multiple patients, including first-in-country cases for systemic sclerosis and MS.
The science evolves quickly. Next-generation designs target additional markers like BCMA or BAFF to spare some healthy B cells and reduce infection risk. Preclinical work explores CAR-Treg cells and other refinements.
So far, the data paint an optimistic picture. Deep B-cell depletion. Drug-free remissions. Improved mobility and daily life. Reduced reliance on chronic medications with their own toxicities.
Janisch-Hanzlik still asks her doctors what comes next. Their answer stays the same. “We don’t know, you’re the first. We’re just going to have to wait and see.”
Thousands more may soon join her. If results hold, CAR-T could shift treatment from symptom control to something closer to reset. The transition from cancer wards to rheumatology clinics continues. Success there would touch millions living with these often debilitating conditions.
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