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VANCOUVER, BC, Oct. 15, 2026 /CNW/ — Three senior figures at the International Society for Cell & Gene Therapy (ISCT) played a central role in drafting updated international consensus recommendations on chimeric antigen receptor (CAR) T-cell therapy for severe autoimmune diseases, published today in The Lancet Rheumatology. Developed alongside the European Society for Blood and Marrow Transplantation (EBMT) and the Joint Accreditation Committee of ISCT and EBMT (JACIE), the guidance spans rheumatic, neurological, and hematological autoimmune conditions — including pediatric cases — and is meant to give multidisciplinary care teams a common, safety-first framework as CAR T therapy moves well beyond oncology.
The list of contributors pairs established cellular therapy expertise with hands-on autoimmune disease knowledge. Dominique Farge, MD, PhD, ISCT Europe Regional Vice President, co-coordinated the recommendations with Raffaella Greco, MD, of IRCCS San Raffaele Hospital in Milan. Fermin Sánchez-Guijo, MD, PhD, a former ISCT Europe Regional Vice President, and Bruce Levine, PhD, a past ISCT President, are also among the co-authors. Levine's work in engineered T-cell therapies spans the earliest years of the field; Sánchez-Guijo, a hematologist based in Salamanca, anchors the transplant and cell-collection perspective. Their counterparts on the EBMT side came from the specialties the document is written for: rheumatology, neurology, pediatrics, hematology, and cellular therapy.
Farge said the field's fast progress would have been unimaginable without close working relationships between cell therapy researchers and autoimmune disease specialists. That same collaboration, she said, shaped the drafting process — and is built into the recommendations themselves.
CAR T therapy for autoimmune disease has traveled an unusually quick path from proof-of-concept to a broad clinical agenda. Early reports of CD19-directed CAR T cells producing deep remissions in treatment-refractory lupus drew immediate attention, and investigators soon extended the approach to systemic sclerosis, inflammatory myopathies, and selected neurological syndromes. The rationale is distinctive: rather than simply suppressing the immune system, CAR T therapy aims to reset it, potentially producing durable treatment-free remissions. That promise explains the unusually close cooperation between transplant specialists and disease-specific experts.
The expansion, however, has exposed significant variability in practice. Centers differ in how they select patients, deliver lymphodepletion, monitor acute toxicities, and judge response. Those inconsistencies make it harder to compare outcomes across studies or translate single-center experience into routine care. The updated consensus was designed to close those gaps, with an explicit pediatric section so child-facing teams no longer have to improvise from adult protocols. For many of these conditions, standard-of-care options remain limited, and registries of patients treated with CAR T cells — encouraged in the guidance — are expected to accelerate learning across centers.
Written for use across treatment settings, the recommendations address patient selection and referral pathways, technical aspects of CAR T manufacturing and delivery, management of infusion-related complications, and definitions of response and long-term follow-up. The aim is practical: give clinicians a clear framework rather than a list of abstract principles.
The document covers multiple autoimmune domains — rheumatic, neurological, and hematological — so that hospitals can apply one consistent set of standards across disease areas. For pediatric patients with severe, refractory autoimmune disease, the guidance provides what has long been missing on paper: a dedicated clinical reference point. The authors also flag areas where evidence remains thin and call for structured data collection to support future revisions. The guidance likewise reflects a broader shift in how these therapies are being evaluated, moving from purely safety-focused trials toward designs that measure meaningful, lasting changes in organ function and quality of life.
One distinctive feature of this update is its proximity to JACIE, the joint accreditation body run by EBMT and ISCT. JACIE standards give cell therapy centers a defined infrastructure for quality management, from collection and manufacturing through clinical delivery.
For US hospital systems, that connection matters. Autoimmune CAR T therapy has until now been delivered mainly inside academic trial frameworks. As more institutions consider offering it in standard care, payers and regulators increasingly want assurance that a center can support such a program end to end — not just that the drug works. The issue is not new: oncology CAR T programs faced similar questions in their early years. But the autoimmune application brings fresh variables, including patients who have not had prior transplants and, in many cases, no prior intensive chemotherapy. Aligning the new recommendations with the JACIE framework gives US hospitals a practical checklist for readiness, program design, and continuous quality improvement.
Publication alone, ISCT argues, is not enough. The society has tied the release to an education effort designed to compress the time between evidence and application. In 2025, its course "The Use of Cell Therapies for Autoimmune Diseases: CAR-T" in Paris convened international faculty, with Farge, Sánchez-Guijo, and Levine as course directors. The program was designed as both a training session and a working forum, and the clinical discussions informed the recommendations as they evolved. The faculty's take-home message was consistent: autoimmune patients are not oncologic patients, and their supportive care, monitoring, and long-term follow-up must be adapted accordingly.
The course has since been reworked into a self-paced online curriculum, extending its reach beyond the live audience. It includes recorded presentations from the Paris faculty, case discussions, and self-assessment tools, letting clinicians work at their own pace. ISCT clinician, resident, fellow, and student members can take the online course free of charge through June 2028 via the ISCT website.
ISCT Chief Medical Officer Jaap Jan Boelens, MD, PhD, an invited speaker at the Paris course, said demand for practical guidance is growing as fast as the science. "Clinicians are asking how these therapies will fit into their own clinics," he said. "Expert-led, accessible education is how we make sure today's advances are adopted safely and reproducibly." He described the rollout of ISCT courses around the world as an investment in the next generation of clinicians and researchers.
With the recommendations out, the focus shifts to translation. Between a Lancet-published consensus, accreditation standards, and open training materials, ISCT and its partners are signaling that best practice in autoimmune CAR T therapy is not a static document but a discipline that needs constant updating — in evidence and skills alike.
Longer follow-up will be essential. Autoimmune patients treated now may need years of observation to confirm durable disease control and to document late toxicities — two areas where the recommendations encourage registries and standardized outcome reporting. For clinicians, the next step is immediate: read the full guidance in The Lancet Rheumatology, or access the online course through the ISCT website. The publication, the quality-assurance linkage, and the training rollout together send a clear message: CAR T therapy for autoimmune disease is being built as a clinical discipline, not a series of isolated experiments.
About ISCT
The International Society for Cell & Gene Therapy (ISCT) is a global society of scientists, clinicians, industry professionals, and regulators working to advance cell and gene therapies from discovery to safe, effective, and accessible patient care.
SOURCE International Society for Cell & Gene Therapy
