NCT06559644尚未招募早期 1 期
Assessment of the Safety and Efficacy of Hema-NeoTIL01 Cell Infusion Therapy in Relapsed/Refractory Acute Leukemia: A Single-Arm, Open-Label, Prospective Study
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- CR/CRi, MRD-negative CR
研究概览
简要总结
This clinical trial aims to investigate the safety, optimal dosage, and effectiveness of autologous tumor-specific T cells, known as Hema-NeoTIL0 in treating relapsed/refractory B-ALL/AML.
详细描述
Primary Objective:
To assess the safety of Hema-NeoTIL01 in the treatment of relapsed/refractory acute leukemia (B-ALL/AML).
Secondary Objective:
To evaluate the efficacy of Hema-NeoTIL01 in relapsed/refractory acute leukemia (B-ALL/AML).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and <70 years old, gender not specified;
- •Diagnosed with B-ALL or AML according to the World Health Organization (WHO) classification of hematopoietic and lymphoid tissue tumors (2022 version);
- •Meet the diagnosis of relapsed/refractory leukemia, excluding isolated extramedullary relapse; For relapsed or refractory ALL, including any of the following situations: a) Relapse: Peripheral blood or bone marrow recurrence of primitive cells >5% or extramedullary lesions appear again after complete remission; b) Refractory: Primary refractory patients who fail to achieve complete remission after standard induction chemotherapy; Or meet the diagnosis of relapsed or refractory AML, including any of the following situations: a) Relapse: Recurrence of primitive cells >5% in bone marrow after complete remission (except for reasons such as bone marrow regeneration after consolidation chemotherapy) or extramedullary infiltration of leukemia cells; b) Refractory: Patients who have failed two cycles of standard treatment; those who relapse within 12 months after CR after consolidation therapy; those who relapse after 12 months and are ineffective after conventional chemotherapy; those with two or more relapses; those with persistent extramedullary leukemia;
- •Patients who have previously received ineffective/relapsed CAR-T cell therapy may be included in this study, provided that the efficacy evaluation of CAR-T therapy has been completed and evaluated as NR, or relapse after remission of CAR-T therapy;
- •Estimated survival >12 weeks;
- •Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
- •Left ventricular ejection fraction (LVEF) ≥50%;
- •Pulmonary function ≤Grade 1 dyspnea (CTCAE v5.0), normal oxygen saturation without oxygen supplementation;
- •Total bilirubin (TBil) ≤3×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5×ULN, creatinine ≤1.6mg/dL;
- •Pregnancy test must be negative, and fertile non-abstinent female patients must agree to use effective contraception from the start of self-screening to 1 year after cell infusion. Fertile male patients with fertile partners must agree to use effective contraception from the start of self-screening to 1 year after cell infusion, and should not donate semen or sperm throughout the study period.
- •The subject and their legal guardian voluntarily participate in this study, understand the trial information and objectives, and provide informed consent with a signed and dated signature.
- •The subject and their legal guardian are willing and able to comply with all trial requirements.
排除标准
- •Patients with a history of severe central nervous system diseases, such as uncontrolled seizures, stroke, severe brain injury resulting in aphasia, paralysis, dementia, Parkinson's disease, psychiatric disorders, etc.;
- •New York Heart Association (NYHA) functional class III or IV heart failure;
- •Any unstable diseases occurring within 6 months before screening (including but not limited to): unstable angina, ischemic or cerebrovascular accidents, myocardial infarction, severe arrhythmias requiring drug treatment (such as rapid atrial fibrillation, high-degree atrioventricular block, ventricular tachycardia, ventricular fibrillation, or torsades de pointes), cardiac catheterization or coronary artery stenting, or coronary artery bypass surgery, thrombotic or embolic events.
- •Presence of disseminated intravascular coagulation;
- •Severe autoimmune diseases or immunodeficiency diseases;
- •Active graft-versus-host disease requiring continued systemic therapy;
- •Subjects receiving systemic corticosteroids or other immunosuppressive therapy before screening, and the investigator determines that they will continue to use long-term therapy after enrollment (excluding inhalation or local use);
- •History of or concomitant active malignant tumors, excluding cured non-invasive basal cell or squamous cell skin cancer, uterine cervical carcinoma in situ or localized prostate cancer or breast ductal carcinoma in situ without recurrence for at least 2 years;
- •Presence of other severe medical conditions as determined by the investigator, such as uncontrolled hypertension or diabetes, severe renal insufficiency, severe pulmonary dysfunction, etc.;
- •Active HBV or HCV infection (HBV-DNA positive or HCV-RNA positive), HIV positive, or syphilis positive;
- •Other severe or persistent active infections;
- •Severity of adverse events related to previous systemic immunotherapy (including other investigational drugs or medical device interventions) at screening not reduced to grade 1 or baseline status;
- •Discontinuation of immunosuppressants within 2 weeks prior to screening;
- •History of allergy to any component of the cell product;
- •Vaccination or any surgical procedure within 4 weeks prior to screening;
- •Other conditions deemed by the investigator to potentially increase subject risk or interfere with trial results.
结局指标
主要结局
CR/CRi, MRD-negative CR
时间窗: Within 28 days after the first dose
Complete remission (CR) is defined as the presence of less than 5% bone marrow blasts in an aspirate containing spicules, accompanied by independence from transfusions. CR with incomplete hematologic recovery (CRi) is defined as the presence of less than 5% bone marrow blasts, with either an absolute neutrophil count (ANC) of less than 1×10\^9/L or a platelet count of less than 100×10\^9/L, while remaining transfusion-independent but exhibiting persistent cytopenia. Minimal residual disease (MRD)-negative CR is defined as a leukemic cell count below the sensitivity threshold of 1×10\^-4 (0.01%) of bone marrow mononuclear cells (MNCs), as measured by multiparameter flow cytometry.
次要结局
- OS(2 years)
- RFS(2 years)
- Adverse events(Within 28 days after the first dose)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
1 期
Gene Therapy for Chronic Granulomatous Disease in KoreaChronic Granulomatous DiseaseNCT00778882Helixmith Co., Ltd.2
招募中
2 期
Autologous Haematopoietic Stem Cell Transplantation for highly active treatment resistant multiple sclerosis.ACTRN12619000348156Alfred Health50
进行中（未招募）
不适用
A pilot study on the safety and efficacy of haemopoietic stem cell mobilization (CD34+ cells) with MOZOBIL ± G-CSF, in adult patients diagnosed with beta-thalassaemia major.Beta-thalassaemia majorMedDRA version: 12.0Level: LLTClassification code 10004505Term: Beta thalassaemiaMedDRA version: 12.0Level: LLTClassification code 10004514Term: Beta-thalassaemiaMedDRA version: 12.0Level: LLTClassification code 10043391Term: Thalassaemia betaEUCTR2009-014136-37-GRniversity of Washington
招募中
1 期
An Open-label Study of a Gene Therapy Product (Vebeglogene Autotemcel) in Transfusion Dependent Beta-ThalassemiaBeta-ThalassemiaNCT06308159Lantu Biopharma6
招募中
1 期
AHSCT Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple MyelomaMultiple MyelomaNCT05740891Zhejiang University50