CAR-T therapy reaches 150 patients in Ireland and expands into autoimmune trials for lupus and MS. Kyverna's miv-cel nears FDA approval for stiff person syndrome, and new research links gene variants to CAR-T outcomes.
Lyell Immunopharma initiated the Phase 3 PiNACLE–H2H trial of ronde-cel in large B-cell lymphoma and reported that GI prophylaxis reduced severe diarrhea rates from 55% to 10% in the Phase 1 LYL273 trial.
Amgen detailed its T-cell engager and precision therapy strategy at Citi's 2026 summit. GT Biopharma, Onco-Innovations, Oncotelic, and Samsung Biologics also advanced AI and organoid platforms in drug development.
Phase I CARLYSLE trial data show CAR-T therapy obe-cel induces remission in severe refractory lupus with a favorable safety profile. Separate case report documents two successful pregnancies after dual-target CAR-T therapy with no transmission to infants.
Sana Biotechnology will present preclinical data for SG293, an in vivo CAR T candidate, at ASGCT 2026. The presentation covers a CD8-targeted fusosome that generates CD19-directed CAR T cells in NHPs.
Swissmedic has authorized three orphan drugs for rare diseases: Breyanzi for mantle cell lymphoma, Alhemo for haemophilia A and B, and Ekterly for hereditary angioedema. The decisions include a new indication extension for Breyanzi, an expanded indication for Alhemo, and the initial authorization of Ekterly as part of a joint international regulatory initiative.
China has approved the world's first CAR-T cell therapy for solid tumors, specifically for stomach cancer, developed by CARsgen Therapeutics. Meanwhile, the WVU Cancer Institute has conducted the first-ever use of a subcutaneous formulation of blinatumomab to achieve remission in a patient with ultra-rare mixed phenotype acute leukemia.
Updated data from the phase I CaMMouflage trial showed CB-011, the first allogeneic anti-BCMA CAR-T therapy with immune cloaking, achieved an approximately 92% overall response rate in relapsed/refractory multiple myeloma. The 2026 Tandem Meetings also highlighted advances in EB-103, KITE-753, and LV20.19 CAR-T constructs across lymphoma and CLL. Separately, NXC-201 reported a 95% complete response rate in AL amyloidosis.
Real-world studies show early complete response after CAR T-cell therapy predicts sustained remission in large B-cell lymphoma, while historical chemotherapy yields poor outcomes in high-risk patients. Data from registries highlight a significant event-free survival advantage for second-line axicabtagene ciloleucel versus standard-of-care salvage therapy.
The phase III frontMIND trial showed that adding tafasitamab and lenalidomide to R-CHOP chemotherapy reduced the risk of progression by 25% in patients with high-risk B-cell lymphomas. The 3-year progression-free survival was 67.3% with the combination versus 60.7% with R-CHOP alone. A dual-targeted CD19/CD20 immunotherapy regimen has also been approved in Australia for relapsed follicular lymphoma.
