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ASH 2025 | CASTLE trial: safety & early efficacy of anti-CD19 CAR-T therapy in systemic autoimmune diseases
Fabian Müller, MD, University Hospital Erlangen, Erlangen, Germany, discusses the final analysis of the CASTLE trial (NCT06347718), a Phase I/II basket trial exploring the safety and preliminary efficacy of the anti-CD19 CAR T-cell product zorpocabtagene autoleucel (zorpo-cel) in patients with severe refractory autoimmune diseases, including lupus, myositis, and systemic sclerosis. Dr Müller highlights that the data confirm earlier findings, with all patients responding and achieving treatment-free remission (TFR). This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
The CASTLE trial is a trial on CD19 CAR T-cell therapy in severe refractory autoimmune disease patients. We have treated lupus, myositis, and systemic sclerosis in different numbers and specific to their individual diseases, age groups, and gender and sex distributions. What is super amazing about the data is that we pretty much confirm what we have been seeing in earlier patients, that all of them do respond, all of them achieve treatment-free remission...
The CASTLE trial is a trial on CD19 CAR T-cell therapy in severe refractory autoimmune disease patients. We have treated lupus, myositis, and systemic sclerosis in different numbers and specific to their individual diseases, age groups, and gender and sex distributions. What is super amazing about the data is that we pretty much confirm what we have been seeing in earlier patients, that all of them do respond, all of them achieve treatment-free remission. So we see reversal of many of the organ problems that they had with their diseases. So it’s very exciting, whereas the disease or the treatment itself is really well-tolerated, we only see very few side effects that are typical for CAR T-cell therapies, like cytokine release syndrome, which means it’s like a cytokine storm in the end when the T-cells are doing their jobs, so the entire setup is really favorable when we think about autoimmune diseases.
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