# FDA批准Calibr-Skaggs的sCAR-T療法用於自體免疫疾病。

*biotech · news · 2026-04-10 · News-Medical.net*

## Key points

- FDA已核准Calibr-Skaggs的IND申請，以研究自體免疫疾病中的sCAR-T療法。
- CLBR001 + SWI019療法在治療自體免疫疾病時免除了淋巴細胞清除的需求。
- 早期試驗顯示，CLBR001細胞在無淋巴細胞清除的情況下擴增能力優於已核准的CAR-T產品。
- CLBR001 + SWI019已展現縮短B細胞惡性腫瘤中細胞激素釋放症候群(CRS)及神經毒性(ICANS)持續時間的能力。
- 第一期試驗將評估該療法在肌炎、系統性硬化症、紅斑性狼瘡及類風濕性關節炎的安全性與有效性。

Calibr-Skaggs Institute for Innovative Medicines, the drug discovery division of Scripps Research, announced today that the FDA has cleared their 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. Calibr-Skaggs' novel sCAR-T therapy is designed to reduce side effects and patient burden associated with prior lymphodepletion treatments required for traditional CAR-T approaches-an important issue for rheumatologists and patients. Autoimmune diseases are often chronic conditions that affect up to ~15 million people in the U.S. and up to 12% of the global population. CAR-T cell therapy has demonstrated curative potential in select autoimmune diseases by creating a system-wide immune 'reset', improving a patient's quality of life, and reducing the need for life-long immune suppressants. However, conventional CAR-T cell therapies require lymphodepletion – a chemotherapy procedure used to eliminate existing immune cells to ensure the CAR-T cells can effectively expand. Further, this procedure can lead to increased risk of infection and severe side effects. CLBR001 + SWI019 was designed to avoid these issues by eliminating the need for lymphodepletion, reducing side effects and potentially making treatment accessible to a broader patient population. Patients with chronic autoimmune diseases need curative options that do not require life-long immunosuppressive therapy to manage their condition. Our CLBR001 + SWI019 cell therapy has the potential to transform the treatment paradigm for patients by eliminating chemotherapy-associated risks." Travis Young, vice president of biologics at Calibr-Skaggs Calibr-Skaggs' Chief Medical Officer Chan Beals says, "Successfully establishing safety and efficacy of CLBR001 + SWI019 for conditions like lupus and rheumatoid arthritis could pave the way for broader therapeutic use in other autoimmune diseases, offering new hope to many more patients in the future." Patient enrollment for the clinical trial is anticipated to begin soon. Interested participants or referring clinicians can find more information by visiting calibr.scripps.edu or clinicaltrials.gov (NCT06913608). About CLBR001 + SWI019 Switchable CAR-T Calibr-Skaggs' CLBR001 + SWI019 switchable CAR-T cell therapy differs from conventional CAR-T approaches by leveraging two components, a sCAR-T cell (CLBR001) and a protein-based biologic "switch" (SWI019) that targets CD19-positive B cells. CLBR001 + SWI019 has already demonstrated promising results in treating patients with B cell malignancies, with the ability to shorten the duration of adverse effects such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and preclinical work has demonstrated the unique ability to work without lymphodepletion. In early-stage trials, CLBR001 cells expanded in patients to higher levels in peripheral blood compared to approved CAR-T cell products, with robust persistence.

**Companies:** Calibr-Skaggs Institute for Innovative Medicines
**Countries:** United States

[Read the full story on News-Medical.net](https://www.news-medical.net/news/20260410/FDA-clears-investigational-new-drug-application-to-test-sCAR-T-therapy-for-autoimmune-conditions.aspx)

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