2025-524993-41-00招募中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) (Breakfree-AiCE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 3
- 试验地点
- 3
- 主要终点
- Safety, including side effects after getting zola-cel and any unusual results in blood test.
研究概览
简要总结
To evaluate the safety and tolerability of zola-cel in participants with ITP and participants with AIHA (Cohort 1 Part A). To evaluate the efficacy of zola-cel in participants with ITP and participants with AIHA (Cohort 1 Part B).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participants with cITP or AIHA.
- •At least 18 years of age.
- •Participants who have received at least 2 previous therapies which either did not work for the person or the person could not continue taking them due to side effects.
- •For cITP, the platelet counts need to be < 30 × 109/L or < 50 × 109/L if on certain medications called TPO-RA.
- •For AIHA, hemolysis needs to be documented by participant's doctor and the hemoglobin needs to be <10 g/dL without red blood cell transfusion, or transfusion dependent
排除标准
- •ITP or AIHA associated with Evans syndrome, other autoimmune disease affecting whole body or a single organ requiring specific medications called immunosuppressants, certain viral-induced conditions including hepatitis C virus and HIV, certain drug and vaccine induced conditions, surgical procedures, hematologic malignancies (blood cancer), or nonblood cancer within 2 years.
研究组 & 干预措施
CD19-Targeted NEX-T CAR T
Test
干预措施: CD19-Targeted NEX-T CAR T (Drug)
结局指标
主要结局
Safety, including side effects after getting zola-cel and any unusual results in blood test.
Safety, including side effects after getting zola-cel and any unusual results in blood test.
Blood Problem Improvement after getting zola-cel.
Blood Problem Improvement after getting zola-cel.
次要结局
- Other types of improvement, how long improvement lasts, need for extra help, other disease-specific health checks, and quality of life.
- Side effects are watched for the whole time after treatment.
研究者
GSM-CT
Scientific
Celgene Corp.
研究点 (3)
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