NCT05827835招募中1 期
A Study to Evaluate the Efficacy and Safety of CD7CAR-T Bridging to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed CD7 Positive Malignant Hematologic Diseases
Zhejiang University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年4月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence and level of AE and SAE
研究概览
简要总结
This is a single-arm, open-label, single-center, phase I/II study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with CD7-positive relapsed or refractory Malignant Hematologic Diseases
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form (ICF)
- •Male or female, older than 18 years (including 18 years)
- •Anticipated survival time more than 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- •According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia and Acute Myeloid Leukemia (
- •v1), patients diagnosed as CD7+ALL and AML
- •Consistent with r/r CD7+acute leukemia diagnosis, including any of the following conditions
- •a. No CR after standard chemotherapy
- •b. The first induction reaches CR, but CR ≤ 12 months
- •c. Patients with r/r CD7+acute leukemia have not responded to the first or multiple remedial treatments
- •d. Multiple recurrences
- •Philadelphia chromosome negative (Ph -) subjects; Or cannot tolerate tyrosine kinase inhibitor (TKI) treatment; Or Philadelphia chromosome positive (Ph+) subjects who did not respond to both TKI treatments
- •Normal lung function, oxygen saturation greater than 92% without oxygen inhalation
- •The blood biochemical test results are consistent with the following results
- •a. (AST) and (ALT) ≤ 2.5 × (ULN)
- •b. Total bilirubin ≤ 1.5 × ULN
- •c. 24-hour serum creatinine clearance ≥ 30 mL/min
- •d. Lipase and amylase ≤ 2 × ULN
- •Fertility capable men and women of childbearing age must agree to use effective contraception starting with the signing of an informed consent form until within 2 years after the use of the study drug. Women of reproductive age include pre menopausal women and women within 2 years after menopause. The blood pregnancy test for women of reproductive age must be negative at screening
排除标准
- •Patients with the history of epilepsy or other CNS disease
- •Pregnant or breastfeeding
- •Active infection with no cure
- •Patients with prolonged QT interval time or severe heart disease
- •Have experienced hypersensitivity or intolerance to any drug used in this study
- •Patients who received anticancer chemotherapy or other drug treatment within 2 weeks before screening
- •Previous malignant tumors that require treatment or have evidence of recurrence within the previous 5 years of screening
- •Clinically significant central nervous system lesions such as seizures, cerebral vascular ischemia/hemorrhage, dementia, cerebellar disease, psychosis, active central nervous system involvement, or cancerous meningitis
- •In the past 2 years, terminal organ damage caused by autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) or the need for systematic application of immunosuppressive or other systemic disease control drugs
- •Severe active viral, bacterial, or uncontrolled systemic fungal infections; Genetic bleeding/coagulation disorders, a history of non-traumatic bleeding or thromboembolism, and other diseases that may increase the risk of bleeding
- •Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during this study
- •Participated in clinical trials of other drugs within 4 weeks or 5 drug half-lives (T1/2) before screening
- •Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
研究组 & 干预措施
Treatment Group
Experimental
R/R CD7+Malignant Hematologic Diseases
干预措施: CD7 CAR-T cells injection (Drug)
Treatment Group
Experimental
R/R CD7+Malignant Hematologic Diseases
干预措施: Allogeneic hematopoietic stem cell transplantation (Other)
结局指标
主要结局
Incidence and level of AE and SAE
时间窗: Baseline up to 28 days after CD7 CAR T-cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
次要结局
- CAR-T cell expression(Evaluate at 1, 2, 3, 4, 8,12,16, 20 and 24 weeks after CAR-T infusion)
- Progression-free survival (PFS)(Month 6,12,18and 24)
- CAR-T related cytokine expression(Evaluate at 1, 2, 3 and 4 weeks after CAR-T infusion)
- Survival Rate （SR）(Evaluate at 6, 9, and 12 months)
- Time-To-Progression（TTP）(Month 2,3,4,6,12,18and 24)
- Duration of remission,DOR(Up to 1 years after Treatment)
- Overall response rate,ORR(Evaluate at 4, 8, and 12 weeks after CAR-T infusion)
- Clinical Benefit Rate（CBR）(Up to 24 weeks after Treatment)
- Disease Control Rate （DCR）(Up to 12 weeks after Treatment)
- Overall survival, OS(Up to 1 years after Treatment)
- Minimal Residual Disease(Up to 2 years after Treatment)
- Bone marrow transplantation STR(Evaluate at 4, 8,12,16 and 20 weeks after allogeneic hematopoietic stem cell transplantation)
研究者
He Huang
Clinical Professor
Zhejiang University
研究点 (1)
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