NCT06718244招募中2 期
A Clinical Study of Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for B-Cell Acute Lymphoblastic Leukemia(B-ALL) Patients in First Complete Remission (CR1)，Minimal Residual Disease(MRD) Positive
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- MRD negativity rate
研究概览
简要总结
This investigator-initiated, prospective, single-arm, open-label, single-center clinical study aims to evaluate the efficacy and safety of Inaticabtagene autoleucel (Inati-cel;CNCT19)CD19 CAR-T theraphy in adults B-ALL that are in first complete remission(CR1) with minimal residual disease (MRD) positivity. This trial will enroll 20 participants for leukapheresis and treatment with lymphodepleting chemotherapy followed by Inati-cel CAR T cell infusion. Patients will be assessed for MRD negativity rate(at months 1, 2, 3, and 6 after CAR-T transfusion), duration of MRD negativity, overall survival(OS), relapse-free survival(RFS), pharmacokinetics(PK) characteristics, incidence of adverse events(AEs), exploratory biomarker research at 1,2,3,6,9,12,15,18,21 and 24- months post Inati-cel infusion.
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
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between ≥16 and ≤70 years at screening, no gender restrictions
- •ECOG score of 0-1 at screening
- •Newly diagnosed Ph-negative B-ALL, MRD positive(bone marrow MRD ≥0.01% by flow cytometry) in CR1 (with <5% blasts in bone marrow, no blasts in peripheral blood, no extramedullary disease)after induction chemotherapy or consolidation chemotherapy.
- •Newly diagnosed Ph-positive B-ALL, MRD positive(bone marrow MRD ≥0.01% by flow cytometry or BCR-ABL1 >0.01% detected by qPCR) in CR1 (with <5% blasts in bone marrow, no blasts in peripheral blood, no extramedullary disease) .
- •At diagnosis of B-ALL,CD19 expression of leukemic cells is positive by flow cytometry in bone marrow or peripheral blood.
- •Appropirate organ function, meeting the following criteria:
- •Aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN);
- •Alanine aminotransferase (ALT) ≤3 times ULN;
- •Total bilirubin ≤2 times ULN (for patients with Gilbert's syndrome, total bilirubin ≤3.0 times ULN and direct bilirubin ≤1.5 times ULN);
- •Serum creatinine ≤1.5 times ULN, or creatinine clearance ≥60 mL/min (using the Cockcroft-Gault formula);
- •International Normalized Ratio (INR) ≤1.5 times ULN and activated partial thromboplastin time (APTT) ≤1.5 times ULN;
- •Left ventricular ejection fraction (LVEF) ≥50%;
- •Minimum pulmonary reserve, with oxygen saturation >91% on room air;
- •Meets leukapheresis standard of the study center, with no contraindications for blood cell separation;
- •Voluntarily agrees to participate in this study and signs on the informed consent form(ICF).
排除标准
- •Received CAR-T cell therapy before screening;
- •Inherited bone marrow failure syndrome(IBMFS) or any other known bone marrow failure syndromes;
- •Active systemic autoimmune diseases requiring treatment;
- •Any of the following conditions:
- •HBsAg and/or HBeAg positive;
- •HBe-Ab and/or HBc-Ab positive with HBV-DNA levels above the lower limit of quantification;
- •HCV-Ab positive;
- •TP-Ab positive;
- •HIV antibody positive;
- •EBV-DNA or CMV-DNA levels above the lower limit of quantification;
- •Active infection at screening.
- •Any other malignancy within the past five years before screening, excluding cases where the patient has been disease-free for more than 5 years after curative treatment or has a low risk of relapse as assessed by the investigator;
- •Any of the following cardiac conditions:
- •NYHA Class III or IV congestive heart failure;
- •Severe arrhythmia requiring treatment;
- •Uncontrolled hypertension or pulmonary hypertension despite standard therapy;
- •Unstable angina;
- •Myocardial infarction, bypass surgery, or stent placement within six months before cell retransfusion;
- •Clinically significant valvular disease;
- •Other cardiac conditions deemed unsuitable by the investigator;
- •History of epilepsy, cerebellar disease, or other active central nervous system disorders;
- •Uncontrolled diabetes;
- •History of symptomatic deep vein thrombosis or pulmonary embolism within six months before screening that is not well controlled;
- •History of hypersensitivity to any component of the investigational product.
- •Received a live vaccine within six weeks before screening;
- •Life expectancy of less than three months;
- •Participation in another interventional clinical trial and receiving investigational drugs within three months (for unapproved drugs) or within five half-lives (for approved drugs) before cell infusion, or plans to participate in another clinical trial or receive anti-cancer therapy outside the study protocol during the study period;
- •Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
研究组 & 干预措施
intervention group
Experimental
Administration with Inaticabtagene autoleucel CD19 CAR-T cells in the MRD positive B-ALL patients in CR1.
干预措施: single dose of Inaticabtagene autoleucel (Biological)
结局指标
主要结局
MRD negativity rate
时间窗: up to 24 months
The proportion of patients who reach MRD negative.Bone marrow of every patient will be analysed by multiparameter flow cytometry or/and RT-qPCR for MRD evaluation.
次要结局
- Duration of MRD negativity(till the end of the study, up to 5 years)
- Relapse-free survival (RFS)(till the end of the study, up to 5 years)
- Overall survival (OS)(till the end of the study, up to 5 years)
- incidence of adverse events(up to 24 months)
- Pharmacokinetics characteristics of Inati-cel(till the end of the study, up to 5 years)
- exploratory biomarker research(till the end of the study, up to 5 years)
研究者
Jin Wang
chief physician, MD, PhD
Ruijin Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for Newly Diagnosed B-cell ALL Patients in CR1Acute Lymphoblastic LeukemiaNCT06777264First Affiliated Hospital of Zhejiang University20
招募中
2 期
Combination of Inaticabtagene Autoleucel With Autologous Hematopoietic Stem Cell Transplantation for Adolescents or Adults With MRD-Positive B-Cell Acute Lymphoblastic Leukemia in Initial Complete Remission.B-cell Acute Lymphoblastic LeukemiaNCT06608732Institute of Hematology & Blood Diseases Hospital, China20
进行中（未招募）
2 期
A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)Lupus Erythematosus, SystemicLupus NephritisNCT06581198Novartis Pharmaceuticals179
招募中
2 期
Adoptive Autologous iNKT Cells for the Treatment of Progressed Hepatocellular Carcinoma Continuing on PD-1 Inhibitor TherapyHepatocellular CarcinomaNCT05962450Beijing YouAn Hospital84
已完成
1 期
A Safety and Efficacy Study of Intetumumab, Alone and in Combination With Dacarbazine, in Participants With Stage 4 MelanomaMelanomaNCT00246012Centocor, Inc.144