NCT07491263尚未招募1 期
Clinical Study of Universal CD19 CAR-γδ T Cell Infusion in the Treatment of Relapsed/Refractory Acute B Lymphoblastic Leukemia
Fujian Medical University1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2026年5月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Incidence of Dose-Limiting Toxicities (DLTs)
研究概览
简要总结
This study is an open-label, single-arm clinical trial designed to evaluate the safety and tolerability of QH103 cell infusion in subjects with CD19-positive R/R B-ALL.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 14 years, gender unrestricted;
- •Clinically diagnosed with relapsed/refractory acute B-lymphoblastic leukemia, with bone marrow blast/immature lymphocyte proportion ≥5% (morphology) (excluding cases with isolated extramedullary involvement), meeting any of the following criteria:
- •Failure to achieve CR after 2 cycles of standard chemotherapy;
- •Initial induction achieved CR, but CR duration ≤12 months;
- •Relapsed/refractory B-ALL refractory to first or multiple salvage therapies;
- •Post-hematopoietic stem cell transplantation relapse, including hematological relapse and minimal residual disease (MRD) positivity;
- •Patients for whom no standard therapy exists.
- •Cytology or histology confirms tumor cell immunophenotype as CD19-positive;
- •Expected survival time exceeding 3 months;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- •Key organ functions meeting the following criteria: left ventricular ejection fraction ≥50% by echocardiography; serum creatinine ≤1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN; total bilirubin ≤1.5 × ULN;
- •Negative pregnancy test for women of childbearing potential; both males and females agree to use effective contraception during treatment and for 1 year thereafter;
- •Toxicity from prior anti-tumor therapy ≤ Grade 1 (according to CTCAE v5.0) or at an acceptable level per inclusion/
排除标准
- •No significant hereditary diseases;
- •Able to comprehend the trial requirements and procedures, and willing to participate in the clinical study as required;
- •Signed informed consent form for the trial
- •Exclusion Criteria:
- •Presence of central nervous system (CNS) involvement or a clinically significant history of CNS diseases, such as epilepsy and cerebrovascular diseases;
- •Pregnant or lactating women, or women who disagree to use effective contraception during treatment and within 1 year after treatment;
- •Other malignancies that are not in remission;
- •Patients with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy;
- •Patients who have received allogeneic immune cell therapy within 6 months before enrollment, or donor lymphocyte infusion within 6 weeks before enrollment;
- •Confirmed positive anti-FMC63 and DSA responses in the patient's serum;
- •Patients who have participated in other clinical trials within 4 weeks before enrollment;
- •Uncontrolled infectious diseases or other serious conditions, including but not limited to infections (human immunodeficiency virus, acute or chronic active hepatitis B or C), congestive heart failure, unstable angina, arrhythmia, or conditions considered by the treating physician to pose unpredictable risks;
- •History of stroke or intracranial hemorrhage within 3 months before enrollment;
- •Major surgery or trauma within 28 days before enrollment, or main side effects not yet recovered;
- •History of allergy to any component of the cell product;
- •Inability to understand or unwillingness to sign the informed consent form;
- •Other reasons deemed by the researchers as unsuitable for the clinical trial.
结局指标
主要结局
Incidence of Dose-Limiting Toxicities (DLTs)
时间窗: 28 days
DLT was defined as QH103 Cells-related events with onset within first 28 days following infusion.
Adverse Event
时间窗: 12 months
次要结局
- PK(Pharmacokinetics):Number and Copy Number of CD19 CAR-γδT cells(12 months)
- PK: Persistence of CD19 CAR-γδT(12 months)
- PD(Pharmacodynamics) ：Changes in Various Cytokine Levels (IL-2, IL-4, IL-6, IFN-γ, TNF α, etc.) from Baseline(12 months)
研究者
Ting YANG
Director of Second Hematology Department and Hematopoietic Stem Cell Transplantation Center
Fujian Medical University
研究点 (1)
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