Plain-English translation of NCT07473154 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.
This is an early-stage trial testing , a new type of cell therapy designed to calm an overactive immune system. The treatment is made from your own immune cells, which are collected, genetically modified in a laboratory to recognize and control B cells (immune cells that cause problems in autoimmune diseases), and then given back to you as a single infusion. Researchers want to see if this medication is safe and whether it helps people with difficult-to-treat rheumatoid arthritis or a serious condition affecting skin and lungs called diffuse cutaneous systemic sclerosis.
Standard treatments don't work well enough for some patients with these two serious autoimmune diseases, and they can have side effects that make them hard to tolerate long-term. This trial exists to explore whether this new treatment approach—using modified versions of your own immune cells—can offer a safer, more effective option.
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If you enroll, your first step will be a procedure called leukapheresis, where blood cells are collected from your arm—similar to donating blood, but the cells are separated and some are returned to you. Your own cells will then be sent to a laboratory to be modified genetically. After that, you'll receive a single intravenous infusion of the modified cells. You'll then attend frequent visits over the first year for blood tests, physical exams, imaging scans, biopsies, and questionnaires to check your safety and how well the treatment is working. After that first year, you'll continue follow-up visits for 15 years total, which is standard for cell therapy trials.
AI-generated summary from trial data · Jul 7, 2026 · Not medical advice
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