NCT07316907尚未招募1 期
An Exploratory Clinical Study of the Safety and Efficacy of Allogenic CD19-Targeted Chimeric Antigen Receptor T-Cell Injection in the Treatment of Relapsed/Refractory B-Cell Hematologic Malignancies
YANRU WANG1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年12月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Toxicity and adverse-event grading after 19UCART treatment
研究概览
简要总结
This is a single-arm, open-label pilot study to evaluate the safety and efficacy of CD19-targeted allogenic CAR-T cells (19UCART) in patients with relapsed/refractory B-cell hematologic malignancies. 12 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study is to evaluation of the safety and feasibility of 19UCART for the treatment of relapsed/refractory B-cell hematologic malignancies. The secondary objective is to evaluate the efficacy of 19UCART for the treatment of relapsed/refractory B-cell hematologic malignancies. The exploratory objective is to evaluate expansion, persistence and ability of 19UCART to deplete CD19 positive cells in patients with relapsed/refractory B-cell hematologic malignancies.
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
- •Voluntary participation in this trial with signed informed consent.
- •Diagnosis of B-cell hematologic malignancy according to the 2017 WHO classification, including B-acute lymphoblastic leukemia (B-ALL) and mature B-cell lymphomas such as diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal-zone lymphoma (MZL), small lymphocytic lymphoma/chronic lymphocytic leukemia (SLL/CLL), mantle-cell lymphoma (MCL), etc.
- •Refractory or relapsed B-cell malignancy defined as failure to achieve complete remission after standard therapy, or relapse after achieving remission with first-line or salvage therapy.
- •Persistence of minimal residual disease (MRD) positivity despite hematologic remission in B-cell acute lymphoblastic leukemia (ALL).
- •At least one measurable lesion ≥1.5 cm in longest diameter by IWG revised criteria for relapsed/refractory lymphoma.
- •Age 18-70 years; both sexes eligible.
- •Expected survival ≥12 weeks.
- •Adequate organ function as follows (no blood products or growth factors within 14 days before first infusion):
- •. Hematology: A. White blood cell count (WBC) ≥3.0×10⁹/L B. Absolute neutrophil count (ANC) ≥1.5×10⁹/L C. Platelet count (PLT) ≥100×10⁹/L D. Hemoglobin (Hb) ≥90 g/L 2). Renal: A. Serum creatinine ≤1.5×ULN or calculated creatinine clearance ≥60 mL/min 3). Cardiac: A. Left ventricular ejection fraction (LVEF) ≥50 % B. QTc (Fridericia) ≤450 ms (men) or ≤470 ms (women) 4). Hepatic: A. Total bilirubin ≤1.5×ULN B. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN if liver involvement) 5). Coagulation: A. International normalized ratio (INR) or Prothrombin time (PT) ≤1.5×ULN B. Activated partial thromboplastin time (APTT) ≤1.5×ULN 6). Pulmonary: Diffusing capacity of the lung (DLCO) ≥50 % of predicted (with or without correction for anemia/alveolar volume).
- •9. ECOG performance status 0-2 at screening.
- •LVEF ≥50 % and no pericardial effusion.
- •At least 2 weeks since last prior therapy (radiation, chemotherapy, monoclonal antibody, or other systemic treatment).
- •12. Recovery to ≤CTCAE Grade 1 for any preceding serious adverse event (SAE).
- •WOCBP* not surgically sterilized must use highly effective contraception from study start through 6 months after last dose; men with WOCBP partners must use highly effective contraception through 3 months after last dose. WOCBP must have negative serum β-hCG within 7 days before first dose and must not be breastfeeding.
- •14. Ability to comply with study visit schedule and all protocol requirements.
- •*WOCBP = women of child-bearing potential
排除标准
- •Subjects with any of the following conditions are ineligible for this trial:
- •Known hypersensitivity, allergic reaction, intolerance, or contraindication to 19UCART or any study-drug component (including fludarabine, cyclophosphamide, or tocilizumab), or history of severe anaphylaxis.
- •Post-allo-HSCT relapse with active graft-versus-host disease requiring systemic corticosteroids or other immunosuppressants.
- •Uncontrolled active infection of any etiology.
- •Active hepatitis B, hepatitis C, or tuberculosis.
- •HIV or syphilis infection.
- •Active autoimmune disease or history of severe autoimmune disorder (as judged by the PI) requiring prolonged immunosuppressive therapy.
- •Congenital or acquired immunodeficiency syndromes.
- •New York Heart Association (NYHA) class III or IV heart failure, unstable angina, myocardial infarction within 6 months, or sustained (>30 s) ventricular arrhythmia.
- •History of epilepsy or other significant central nervous system disorders.
- •Extra-nodal lymphomatous involvement of brain, lung, or gastrointestinal tract.
- •Prior malignancy other than:
- •Curatively resected non-melanoma skin cancer (e.g., basal-cell carcinoma)
- •Curatively treated carcinoma in situ (cervical, bladder, breast, etc.)
- •Systemic high-dose corticosteroids within 2 weeks before study entry.
- •Pregnancy, lactation, or intention to become pregnant within 6 months.
- •Participation in another clinical trial within 1 month.
- •Anticipated need for any other systemic anti-neoplastic therapy during the study.
- •Major surgery within 14 days before first study-drug administration.
- •Any condition that, in the investigator's opinion, could increase patient risk or interfere with study results.
研究组 & 干预措施
relapsed/refractory B-cell hematologic malignancies
Experimental
relapsed/refractory B-cell hematologic malignancies patients to be treated with 19UCART cells
干预措施: 19UCART injection (Biological)
结局指标
主要结局
Toxicity and adverse-event grading after 19UCART treatment
时间窗: up to 12 months after infusion
all toxicities and AEs will be assessed according to the National Cancer Institute CTCAE v5.0
CRS grading after 19UCART treatment
时间窗: up to 12 months after infusion
CRS will be graded using the Lee DW et al. CRS grading scale
次要结局
- Overall response rate (ORR = CR + PR) of patients receive 19UCART treatment(1, 3, 6, and 12 months after infusion)
- CAR copies and cell count of CAR-T in blood after 19UCART treatment(Day 0, 1, 3, 5, 7, 9, 11, 14, 21, 28, and month 2, 3, 6, 9, 12 after infusion)
- Disease control rate (DCR = CR + PR + SD) of patients receive 19UCART treatment(1, 3, 6, and 12 months after infusion)
- PET-CT Response Criteria according to Lugano metabolic response categories(1, 3, 6, and 12 months after infusion)
研究者
YANRU WANG
Clinical Professor
Affiliated Hospital of Jiangsu University
研究点 (1)
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