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临床试验 NCT06769191 针对Schimke Immuno-osseous Dysplasia目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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浙江大学Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell Sequential Allo-HSCT and Kidney Transplantation in the Treatment of SIOD 早期I期 20
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临床试验NCT06769191旨在研究治疗，主要针对Schimke Immuno-osseous Dysplasia。这是一项早期I期 干预性研究试验，目前试验状态为招募中。试验始于2025年1月30日，计划招募20名患者。该研究由浙江大学主导，预计于2028年1月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年1月20日。
简要概括
A Clinical Study on the Safety and Effectiveness of CD7 CAR-T Cell Sequential Allo-HSCT and Kidney Transplantation in the treatment of Schimke immuno-osseous dysplasia
详细描述
This is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety and efficacy of CD7 CAR-T Cell Sequential Allo-HSCT and Kidney Transplantation in patients with Schimke immuno-osseous dysplasia. It is planned to enroll 20 participants in this trial.
官方标题
Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell Sequential Allogeneic Hematopoietic Stem Cell Transplantation and Kidney Transplantation in the Treatment of Schimke Immuno-osseous Dysplasia
疾病
Schimke Immuno-osseous Dysplasia其他研究标识符
- TXB2024022
NCT编号
实际开始日期
2025-01-30
最近更新发布
2025-01-20
预计完成日期
2028-01-30
计划入组人数
20
研究类型
干预性研究
试验分期 (阶段)
早期I期
试验状态
招募中
关键词
CAR-T
Allo-HSCT
Kidney Transplantation
Allo-HSCT
Kidney Transplantation
主要目的
治疗方法
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Treatment Group Schimke Immuno-osseous Dysplasia | CD7 CAR-T cells injection Intravenous infusion, single dose 异基因造血干细胞移植 (allo-HSCT) allogeneic hematopoietic stem cell transplantation 肾移植 Kidney Transplantation |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Incidence of treatment-emergent adverse events (TEAEs) | Incidence of treatment-emergent adverse events | Up to 2 years after Treatment |
Transplant related mortality rate | The proportion of patients who died after transplantation to the total number of transplant patients during the same period | Up to 100 days after Treatment |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Allogeneic hematopoietic stem cell transplant implantation rate | The proportion of the number of patients who achieved hematopoietic reconstitution to the total number of allogeneic hematopoietic stem cell transplantation patients in the same period. | Up to 100 days after Treatment |
Kidney transplantation implantation rate | The ratio of successfully implanted kidneys to the total implanted kidneys | Up to 100 days after Treatment |
Time to neutrophil and platelet engraftment | The time for neutrophils and platelets to reach the implantation criteria after stem cell reinfusion | Up to 30 days after Treatment |
Disease-feesurvival，DFS | The proportion of disease-free patients who survived to the total number of patients who transplanted allogeneic hematopoietic stem cells during the same period. | Up to 2 years after Treatment |
Overall survival, OS | After transplantation until death from any cause. | Up to 2 years after Treatment |
参与助手
资格标准
适龄参与研究
儿童, 成人, 老年人
适龄性别
全部
- 1. Diagnosed as SIOD and was in stage 5 of chronic kidney disease
- 2. Having allogeneic HSCT indications, at least suitable donors (relatives) for haploidentical allogeneic transplantation and kidneys from stem cell transplantation donors;
- 3. serum total bilirubin ≤ 1.5 times the upper limit of normal, and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were both ≤ 3 times the upper limit of the normal range.
- 4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
- 5. There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%；
- 6. Estimated survival time ≥ 3 months;
- 7. ECOG performance status 0 to 1;
- 8. Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
- 9. Those who voluntarily participated in this trial and provided informed consent;
- 1. Allergic to pretreatment measures
- 2. received any containing ATG/ALG such IST、alemtuzumab、high-dose cyclophosphamide (≥ 45mg/kg/day) , received CsA treatment within 6 months, or used thrombopoietin receptor (tpo-r) agonists in the past;
- 3. Patients with the history of epilepsy or other CNS disease;
- 4. Patients with prolonged QT interval time or severe heart disease;
- 5. Previous recipients of allogeneic hematopoietic stem cell transplantation or organ transplantation
- 6. People infected with HIV, active hepatitis B or hepatitis C virus, and patients with active infection who are not cured;
- 7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- 8. Patients with malignant tumor;
- 9. People with other genetic diseases；
- 10. After receiving CD7 car-t treatment, patients who were unable to accept subsequent kidney transplantation due to severe infection or poor amplification of car-t in vivo.
- 11. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.
Yake Biotechnology Ltd.研究责任方
He Huang, 主要研究者, Principal Investigator, First Affiliated Hospital of Zhejiang University
研究中心联系人
联系人: He Huang, MD, 057187233772, [email protected]
联系人: Yongxian Hu, MD, 057187233772, [email protected]
1 位于 1 个国家/地区的研究中心
Zhejiang
The first affiliated hospital of medical college of zhejiang university, Hangzhou, Zhejiang, 310003, China
He Huang, MD, 联系人, 0571-87233772, [email protected]
Yongxian Hu, MD, 联系人, 0571-87233772, [email protected]
招募中