FDA clears IND for clinical trial testing switchable CAR-T therapy in patients with autoimmune diseases, without chemotherapy

Posted by Michael Jannicelli | Apr 13, 2025 | Uncategorized | 0 |

FDA has cleared an investigational new drug (IND) application to study switchable chimeric antigen receptor T cell (sCAR-T) therapy (CLBR001 + SWI019) in patients with autoimmune conditions. Patient recruitment for the phase 1 trial will begin soon (NCT06913608). The phase 1 clinical trial will evaluate the safety and efficacy of CLBR001 + SWI019 in patients with myositis, systemic sclerosis, lupus and rheumatoid arthritis, with the potential to expand to other indications in the future.

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Michael Jannicelli

Michael Jannicelli - "A PROVEN BUSINESS FIRESTARTER & BRANDING GENIUS" a true natural born Trendsetter. • Created over 100 products under 3 brands, sold in 30+ countries worldwide and influencing youth across the globe. • Featured in Forbes magazine +over 100 print publications, television talk shows, major motion pictures and national radio stations. • Co-founder and VP of Bliss beverage USA and President/co-founder of Socko International - fastest growing privately held beverage company in US (Forbes) with Hogan Energy & Raw Energy WWE. • Co-founder of Throwdown Industries (2003) - leading brand in multibillion dollar Impact/Action Sports Market (products designed for superior MN • Diagnosed with auto-immune diseases aged 13; using his experience to help others and promote a positive message while developing edgy products to benefit people with chronic illness.