NCT04227015招募中早期 1 期
A Study of CTA101 UCAR-T Cell Injection in Patients With Relapsed or Refractory CD19+ B-line Hematological Malignancy
He Huang1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2020年1月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
A study of CTA101 UCAR-T cell injection in patients with relapsed or refractory CD19+ B-line hematological malignancy
详细描述
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy: B-ALL and B-NHL. the selection of dose levels and the number of subjects are based on clinical tiral of similar foreign products. 2 groups of patients will be enrolled, 36 in each group. Primary objective is to explore the safety, main consideration is dose-related safety.
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
- 3 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria applicable to ALL only:
- •Male or female aged ≥ 3 and <70 years old;
- •Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);
- •Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
- •CR not achieved after standardized chemotherapy;
- •CR achieved following the first induction, but CR duration is ≤ 12 months;
- •Ineffective after first or multiple remedial treatments;
- •2 or more recurrences;
- •The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is >5% (morphology) and/or >1% (Flow cytometry);
- •Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
- •Inclusion criteria applicable to NHL only:
- •Male or female aged ≥ 18 and <70 years old;
- •Histologically confirmed diagnosis per WHO Classification Criteria for Lymphocytic Tumors 2016, including DLBCL(NOS), follicular lymphoma, Chronic lymphoblastic leukemia/small lymphoblastic lymphoma transforms DLBCL, PMBCL and high grade B cell lymphoma;
- •Relapsed or refractory DLBCL (meeting one of the following conditions):
- •No remission or recurrence after receiving second-line or above second-line chemotherapy;
- •Primary drug resistance;
- •Recurrence after autologous hematopoietic stem cell transplantation
- •According to Lugano 2014, there should be at least one evaluable tumor lesion.
- •Applicable standards for ALL and NHL:
- •HLA antibody(-) or HLA antibody(+) and HLA donor specific antibody(DSA)(-);
- •total bilirubin ≤ 51umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8umol/L;
- •Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
- •No active infection in the lungs, blood oxygen saturation by sucking air is ≥ 92%;
- •Estimated survival time ≥ 3 months;
- •ECOG performance status 0 to 2;
- •Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
排除标准
- •patients with extramedullary lesions, except those with CNSL (CNS-1) under effective control (for ALL patients only);
- •Confirmed diagnosis of lymphoblastic crisis of chronic myeloid leukemia, Burkitt's leukemia/lymphoma per WHO Classification Criteria (for ALL patients only);
- •Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome (for ALL patients only);
- •patients with intracranial extralateral lesions (cerebrospinal fluid tumor cells and/or intracranial lymphoma invasion shown by MRI) (for NHL patients only) ;
- •extensive involvement of gastrointestinal lymphoma (for NHL patients only);
- •radiotherapy, chemotherapy and monoclonal antibody within 1 week before screening;
- •Have a history of allergy to any of the components in the cell products;
- •Prior treatment with any CAR T cell product or other genetically-modified T cell therapies;
- •According to the New York heart association (NYHA) cardiac function classification criteria, Subjects with grade III or IV cardiac insufficiency;
- •Myocardial infarction, cardioangioplasty or stenting, unstable angina pectoris, or other severe cardiac diseases within 12 months of enrollment;
- •Severe primary or secondary hypertension of grade 3 or above (WHO Hypertension Guidelines, 1999);
- •Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- •History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
- •Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis).
- •Indwelling catheters in vivo (e.g. percutaneous nephrostomy, Foley catheter, bile duct catheter, or pleural/peritoneal/pericardial catheter). Ommaya storage, dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are allowed;
- •History of other primary cancer, except for the following conditions:
- •Cured non-melanoma after resection, such as basal cell carcinoma of the skin;
- •Cervical cancer in situ, localized prostate cancer, ductal cancer in situ with disease-free survival ≥ 2 years after adequate treatment;
- •Patients with autoimmune diseases requiring treatment, patients with immunodeficiency or requiring immunosuppressive therapy;
- •Patients with graft-versus-host disease (GVHD);
- •Prior immunizations with live vaccine 4 weeks prior to screening;
- •History of alcoholism, drug abuse or mental illness;
- •If HBsAg positive at screening, HBV DNA copy number detected by PCR in patients with active hepatitis B > 1000 (if HBV DNA copy number≤1000, routine antiviral therapy is required after enrollment), as well as CMV, hepatitis C, syphilis infection;
- •Concurrent therapy with systemic steroids within 1 week prior to screening, except for the patients recently or currently receiving inhaled steroids;
- •Patients who have participated in any other clinical studies within 2 weeks prior to screening;
- •pregnant and breast-feeding women and the subjects who are fertile and unable to take effective contraceptive measures (regardless of the gender);
- •Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
研究组 & 干预措施
Administration of CTA101
Experimental
Dose escalation follows the standard 3+3 dose escalation design. A total of 2 dose levels are set for subjects.
干预措施: CTA101 (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Baseline up to 28 days after CTA101 infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to 2 years after CTA101 infusion
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
次要结局
- B-cell acute lymphocytic leukemia (B-ALL), MRD negative overall response rate (MRD- ORR)(3 months)
- B-ALL, Event-free survival (EFS)(Month 6, 12, 18 and 24)
- B-ALL, Overall response rate (ORR)(Month 6, 12, 18 and 24)
- B-ALL, Overall survival (OS)(Month 6, 12, 18 and 24)
- B cell non-hodgkin's lymphoma (B-NHL), Overall response rate (ORR)(weeks 4, 12, months 6, 12, 18 and 24)
- B-NHL,disease control rate (DCR)(weeks 12, months 6, 12, 18 and 24)
研究者
He Huang
Clinical Professor
Zhejiang University
研究点 (1)
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