NCT06985498暂停2 期
Safety and Efficacy of Pre-Auto-HSCT Immunotherapy Combined With Auto-HSCT Followed by the CD22/CD19 CAR-T Sandwich Strategy for AYA and Adult B-cell Acute Lymphoblastic Leukemia
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Chimeric antigen receptor T-cell (CAR-T) therapy has achieved remarkable efficacy in B-cell acute lymphoblastic leukemia (B-ALL). However, relapse after CAR-T has been a major issue. Multi-antigen CAR T and combination with other regimens may reduce the relapse rate. We conduct pre-auto-HSCT immunotherapy to achieve MRD negative remission, then perform auto-HSCT followed by CD22/CD19 CAR-T "sandwich " strategy in AYA and adult patients with B-ALL. The main Purpose of this study was to observe the safety and efficacy of this new strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patients with Philadelphia chromosome (Ph)-negative B-cell acute lymphoblastic leukemia (B-ALL) or Ph-positive B-ALL in the high-risk group who have received standard induction chemotherapy; Patients with relapsed/refractory or MRD-positive B-ALL after any course of treatment without a history of immunotherapies（i.e. CD19-directed CD3 T-cell engager, inotuzumab ozogamicin, CD19 or/and CD22 CAR-T cell therapy）, who also meet any of the following criteria: (a) Ineligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT). (b) Refuse allo-HSCT;
- •positive expression of CD19 and CD22 in peripheral blood or bone marrow primary cells detected by flow cytometry;
- •cardiac ultrasound left ventricular ejection fraction ≥ 50%; Creatinine ≤ 1.6 mg/dl; alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the normal range and total bilirubin ≤ 2.0 mg/dl; Pulmonary function ≤ grade 1 dyspnea (CTCAE v5.0) with oxygen saturation > 91% without oxygenation;
- •subjects aged 15-65 years (including 15 and 65 years), regardless of gender;
- •T-cell amplification test pass;
- •expected survival > 3 months.
排除标准
- •Patients who are relapsed/refractory or MRD-positive following treatment with CD19-directed CD3 T-cell engager, inotuzumab ozogamicin, CD19 or/and CD22 CAR-T cell therapy or allo-HSCT;
- •Patients with KMT2A rearrangement
- •patients with recurrence of only isolated extramedullary lesions;
- •combination of other malignant tumors;
- •previously treated with anti-CD19 or/and CD22 or/and CD3 therapies;
- •immunosuppressants use within 2 weeks prior to signing informed consent or plan to immunosuppressants after signing informed consent;
- •Presence of bacterial, fungal, viral, mycoplasmal, or other types of infection that the investigator determines to be difficult to control;
- •Patients with history of hepatitis B (HBsAg positive)or prior hepatitis B infection (defined as HBcAb positive, HBsAg negative) are eligible for enrollment provided that HBV DNA testing by PCR is negative; these subjects must undergo monthly PCR testing for HBV DNA. Patients with positive HCV antibody serology are eligible for enrollment if HCV RNA testing by PCR is negative. Positive for Treponema pallidum antibody (TP-Ab). Positive for human immunodeficiency virus (HIV) antibody.
- •History of severe immediate hypersensitivity reaction to any drug used in this study.
- •history or presence of clinically relevant Central Nervous System (CNS) pathology, such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
- •Pregnant or lactating women.
- •Patients with primary immunodeficiency.
研究组 & 干预措施
Sandwich strategy
Experimental
干预措施: Sandwich stratergy (Combination Product)
结局指标
主要结局
Overall survival
时间窗: 2 years
It is measured from the date of the first course of immunotherapy to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive
次要结局
- leukemia free survival(2 years)
- Number of adverse events(2 years)
研究者
Sheng-Li Xue, MD
Prof.
The First Affiliated Hospital of Soochow University
研究点 (1)
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