A Phase lb Open-Label Study Evaluating the Safety and Efficacy of the Combination of CLBR00l, an Engineered Autologous T Cell Product, and SWI019, a CD19-directed Antibody-based Biologic With or Without Lymphodepletion in Subjects With Autoimmune Disorders Including Systemic Lupus Erythematosus, Systemic Sclerosis, or Idiopathic Inflammatory Myositis

The goal of this clinical trial is to evaluate CLBR001 and SWI019 as a treatment for patients with autoimmune disorders, including systemic lupus erythematosus, systemic sclerosis, and idiopathic inflammatory myositis. Patients will be randomized 1:1 lymphodepletion vs no lymphodepletion arm. Patients will be administered a single infusion of CLBR001 cells followed by cycles of SWI019 with regular assessments of safety and disease response to treatment.
The goals are to establish the safety and efficacy of the combination therapy and determine if lymphodepletion is required for efficacy.

开始日期2025-05-01

申办/合作机构

California Institute for Biomedical Research

NCT06878248

/ Recruiting临床1期IIT

A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Combination of CLBR001, an Engineered Autologous T Cell Product, and ABBV-461, an Antibody-Based Biologic, in Subjects With Locally Advanced or Metastatic Breast Cancer

The goal of this clinical trial is to evaluate CLBR001 and ABBV-461 as a treatment for patients with locally advanced or metastatic breast cancer. The goals are to establish the safety and efficacy of the combination therapy while establishing the optimal biologic doses.
Patients will be administered a single infusion of CLBR001 cells followed by cycles of ABBV-461 with regular assessments of safety and disease response to treatment.

开始日期2025-04-17

申办/合作机构

California Institute for Biomedical Research

NCT04488354

/ Enrolling by invitation临床1期IIT

A Study to Evaluate the Long-Term Safety of CLBR001, A Lentiviral Based Chimeric Antigen Receptor, In Patients With B-Cell Malignancies Previously Administered CLBR001

This study is designed as a long-term follow-up study of participants who have receive genetically modified autologous CLBR001 CAR-T cells

开始日期2021-01-21

申办/合作机构

California Institute for Biomedical Research

100 项与 CLBR-001 相关的临床结果

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100 项与 CLBR-001 相关的转化医学

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100 项与 CLBR-001 相关的专利（医药）

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100 项与 CLBR-001 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
肾外狼疮	临床1期	-	California Institute for Biomedical Research	2025-05-01
特发性炎症性肌病	临床1期	-	California Institute for Biomedical Research	2025-05-01
系统性硬皮病	临床1期	-	California Institute for Biomedical Research	2025-05-01
HER2阳性乳腺癌	临床1期	美国	California Institute for Biomedical Research	2025-04-17
HR阳性乳腺癌	临床1期	美国	California Institute for Biomedical Research	2025-04-17
局部晚期乳腺癌	临床1期	美国	California Institute for Biomedical Research	2025-04-17
转移性乳腺癌	临床1期	美国	California Institute for Biomedical Research	2025-04-17
三阴性乳腺癌	临床1期	美国	California Institute for Biomedical Research	2025-04-17
伯基特淋巴瘤	临床1期	美国	California Institute for Biomedical Research	2021-01-21
慢性淋巴细胞白血病	临床1期	美国	California Institute for Biomedical Research	2021-01-21