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:
适应症
干预措施
相关药物
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
- 主要终点
- Cohort 1 Part A: Number of participants with serious AEs (SAEs)
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: Fludarabine Phosphate (Drug)
Cohort 1 Part B
Experimental
干预措施: BMS-986353 (Biological)
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)
结局指标
主要结局
Cohort 1 Part A: Number of participants with serious AEs (SAEs)
时间窗: Up to approximately Month 36
Cohort 1 Part A: Number of participants with treatment-emergent adverse events (TEAEs)
时间窗: Up to approximately Month 36
Cohort 1 Part A: Number of participants with AEs of special interest (AESI)
时间窗: Up to approximately Month 36
Cohort 1 Part A: Number of participants with clinically significant laboratory abnormalities
时间窗: Up to approximately Month 36
Cohort 1 Part B: Hematologic Complete Response (CR)
时间窗: Up to approximately Month 6
次要结局
- Time to First Complete Response (TTCR)(Up to approximately Month 36)
- Duration of response (DOR)(Up to approximately Month 36)
- Treatment-free Remission (TFR)(Up to approximately Month 36)
- Proportion of participants who requires rescue therapy for ITP or AIHA(Up to approximately Month 36)
- Time to first administration of rescue therapy for ITP or AIHA(Up to approximately Month 36)
- Proportion of AIHA participants who experience hemolysis features(Up to approximately Month 36)
- Number of AIHA participants with cold agglutinin disease (CAD) who experience acrocyanosis(Up to approximately Month 36)
- Change from baseline in hemolysis indicators in AIHA participants(Up to approximately Month 36)
- Proportion of ITP participants with WHO-classified bleeding events as assessed by WHO bleeding scale(Up to approximately Month 36)
- Change from baseline in 36-Item Short Form Health Questionnaire version 2 (SF-36 v2)(Up to approximately Month 36)
- Change from baseline in Patient Global Impression of Severity (PGI-S) Fatigue score(Up to approximately Month 36)
- Patient Global Impression of Change (PGI-C) Fatigue mean score(Up to approximately Month 36)
- Change from baseline in Immune Thrombocytopenia-Patient Assessment Questionnaire (ITP - PAQ) score(Up to approximately Month 36)
- Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score(Up to approximately Month 36)
- Cohort 1 PART B: Hematologic Overall Response (OR)(Up to approximately Month 6)
- Cohort 1 PART A and Cohort 2: Hematologic CR and OR(Up to approximately Month 6)
- Cohort 1 PART B and Cohort 2: Number of participants with TEAEs(Up to approximately Month 36)
- Cohort 1 PART B and Cohort 2: Number of participants with SAEs(Up to approximately Month 36)
- Cohort 1 PART B and Cohort 2: Number of participants with AESIs(Up to approximately Month 36)
- Cohort 1 PART B and Cohort 2: Number of participants with clinically significant laboratory abnormalities(Up to approximately Month 36)
- Number of participants with Hematologic PR(Up to approximately Month 6)
- Number of participants with Hematologic CR(Up to approximately Month 36)
- Number of participants with Hematologic PR(Up to approximately Month 36)
- Number of participants with Hematologic OR(Up to approximately Month 36)
- Number of participants with Best Overall Response (BOR)(Up to approximately Month 36)
- Number of participants with durable CR, PR and OR(Up to approximately 12 months from Zola-cel infusion)
- Time to First Response (TTR)(Up to approximately Month 36)
研究者
研究点 (8)
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