NCT07603557尚未招募2 期
A Phase 2, Multicenter, Open-Label Study of Zolacabtagene Autoleucel (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Chronic Immune Thrombocytopenia (cITP) and Autoimmune Hemolytic Anemia (AIHA)
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company8 个研究点 分布在 4 个国家目标入组 52 人开始时间: 2026年8月31日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 8
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Zola-cel (BMS-986353), in participants with chronic immune thrombocytopenia (cITP) and autoimmune hemolytic anemia (AIHA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria for ITP
- •Documented clinical diagnosis of chronic ITP (cITP) without other clinical manifestations of systemic autoimmune disease.
- •Has relapsed after or is intolerant to corticosteroids (with or without intravenous immunoglobulin (IVIG) or anti-Rh0(D) Ig) AND has failed, relapsed after, or is intolerant to therapies with ≥ 2 mechanisms of action, with at least one being immunosuppressive or immunomodulatory.
- •Platelet count < 30 × 109/L. For participants on thrombopoietin receptor agonist (TPO-RA): platelet count < 50 × 109/L.
- •Inclusion Criteria for AIHA
- •Documented clinical diagnosis of AIHA (including warm autoimmune hemolytic anemia (wAIHA), cold agglutinin disease (CAD), or mixed AIHA) without other clinical manifestations of systemic autoimmune disease.
- •o wAIHA and mixed warm and cold AIHA: Failed, relapsed after, or is intolerant to at least 2 prior lines of treatment with 2 mechanisms of action (not including corticosteroids or IVIG), one of which is an anti-CD20 monoclonal antibody unless there is a documented contraindication.
- •o CAD (all of the following must apply): Failed, relapsed after, or is intolerant to at least 2 prior lines of treatment with 2 mechanisms of action, one of which is an anti-CD20 monoclonal antibody with or without chemotherapy unless there is a documented contraindication.
- •Hb <10 g/dL without red blood cell transfusion, or transfusion dependent
- •Documented hemolysis
排除标准
- •Medical Conditions
- •ITP or AIHA associated with: Evans syndrome, other systemic autoimmune disease or single organ autoimmune disease requiring systemic immunosuppressive therapy, hepatitis C virus, HIV, drug induced (eg, non-steroidal anti-inflammatory drug (NSAIDS), trimethoprim/sulfamethoxazole (TMP-SMX), anticonvulsants), surgical procedures, or hematologic malignancies.
- •COVID-19 Vaccine-induced immune thrombotic thrombocytopenia
- •Prior history of solid organ malignancies, unless the participant has been free of the disease for ≥ 2 years.
- •Laboratory Test Findings
- •Peripheral blood ANC < 1.5 × 109/L or requiring G-CSF or GM-CSF support o ALT/AST: ITP: ALT/AST: > 3 × ULN AIHA: ALT > 3 ULN. AST up to 5 × ULN may be permitted. o Bilirubin: ITP: total bilirubin > 1.5 × ULN AIHA: direct bilirubin > 1.5 × ULN o International normalized ratio (INR) > 1.5 × ULN
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Cohort 1 Part B
Experimental
干预措施: BMS-986353 (Biological)
Cohort 1 Part B
Experimental
干预措施: Fludarabine Phosphate (Drug)
Cohort 1 Part A ITP
Experimental
干预措施: BMS-986353 (Biological)
Cohort 1 Part A ITP
Experimental
干预措施: Fludarabine Phosphate (Drug)
Cohort 2
Experimental
干预措施: BMS-986353 (Biological)
Cohort 1 Part A AIHA
Experimental
干预措施: BMS-986353 (Biological)
Cohort 1 Part A ITP
Experimental
干预措施: Cyclophosphamide (Drug)
Cohort 2
Experimental
干预措施: Cyclophosphamide (Drug)
Cohort 2
Experimental
干预措施: Fludarabine Phosphate (Drug)
Cohort 1 Part A AIHA
Experimental
干预措施: Fludarabine Phosphate (Drug)
Cohort 1 Part A AIHA
Experimental
干预措施: Cyclophosphamide (Drug)
Cohort 1 Part B
Experimental
干预措施: Cyclophosphamide (Drug)
研究者
研究点 (8)
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