ASH 2024 | An ongoing Phase I trial of CD19-directed CAR-T therapy for severe, refractory autoimmune diseases
Paolo Caimi, MD, Cleveland Clinic, Cleveland, OH, comments on the tolerability and efficacy of CC-97540, a CD19-directed CAR T-cell therapy manufactured using a next-generation process, for treating severe, refractory autoimmune diseases. Dr Caimi highlights that patients with these non-malignant autoimmune conditions required lower doses of CAR T-cells than those utilized to treat hematological malignancies, such as lymphoma. The CAR-T product was well-tolerated by patients in an ongoing Phase I study (NCT05869955) and showed significant improvement in disease severity scores, particularly in patients with systemic lupus erythematosus (SLE). This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript
This report is the cumulative experience of multiple centers treating patients with inflammatory conditions that are not oncologic, including lupus erythematosus, as well as inflammatory myositis and systemic sclerosis on the rheumatologic disorders and multiple sclerosis on neurologic diseases, using CAR T-cells that are manufactured by BMS, using the NEX-T platform, which is a more rapid manufacturing platform, and generating cells for treatment of these immune inflammatory disorders...
This report is the cumulative experience of multiple centers treating patients with inflammatory conditions that are not oncologic, including lupus erythematosus, as well as inflammatory myositis and systemic sclerosis on the rheumatologic disorders and multiple sclerosis on neurologic diseases, using CAR T-cells that are manufactured by BMS, using the NEX-T platform, which is a more rapid manufacturing platform, and generating cells for treatment of these immune inflammatory disorders.
The experience includes seven patients, most of whom had systemic lupus erythematosus. And what we found was that patients required very low doses of CAR T-cells compared to what is used and what is currently approved for lymphoma. So these are smaller numbers of CAR T-cells and that they were extremely well tolerated with only one patient of seven patients having low-grade cytokine release syndrome. We did not see any patients experiencing neurologic disorders. And in addition, we saw that most of the lupus patients had an improvement in their severity scores, showing that we can control these immune autoimmune disorders with CAR T-cells targeted to CD19.
The tolerability of these products and the fact that it’s a single treatment, and in addition, with patients who were heavily pretreated and resistant to therapy, suggests that using these treatments that were previously reserved for cancer patients, now using them for patients with diseases that are very severe, that can impact the quality of life of younger patients as well, can make a significant impact on their course of disease and their quality of life.
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Disclosures
Abbvie: Honoraria, Research Funding; BMS: Other: Avisory Board, Research Funding; Novartis: Other: Advisory Board; Genentech: Other: Advisory Board, Research Funding; Synthekine: Other: Advisory Board, Research Funding; Sobi: Honoraria; Recordati: Honoraria, Research Funding; Abcon: Research Funding; Luminary Therapeutics: Other: Scientific Advisory Board, Research Funding; Genmab: Research Funding; ADC Therapeutics: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Profound Bio: Research Funding; Arvinas: Honoraria, Research Funding.
