NCT07211048招募中不适用
Early Exploratory Clinical Study of CD19-targeted Gene Injection (LCAR02) in Patients With Relapsed/Refractory B-cell Lymphoma
Anhui Provincial Hospital1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2026年3月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This is an open label, single-site, dose-escalation study in up to 18 participants with treatment of relapsed/refractory B-cell lymphoma. This study aims to evaluate the safety and efficacy of the treatment with an Anti- CD19 gene injection
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1)Age 18 years or older, any gender; (2)Patients diagnosed with any of the following conditions: diffuse large B-cell lymphoma (DLBCL), germinal center or activated B-cell type; primary cutaneous DLBCL; primary mediastinal (thymic) large B-cell lymphoma; ALK-positive anaplastic large B-cell lymphoma; high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements; high-grade B-cell lymphoma; T-cell-rich B-cell lymphoma; transformed follicular lymphoma; or any aggressive B-cell lymphoma arising from indolent lymphoma; follicular lymphoma; mantle cell lymphoma; large cell transformation of CLL. Patients must have previously received at least second-line standard treatment and either did not achieve remission or relapsed after remission; (3) For B-cell lymphoma patients, according to the preliminary assessment, staging, and response evaluation recommendations for Hodgkin and non-Hodgkin lymphomas (2014 edition), there must be at least one measurable lesion at baseline, which is defined as a lymph node lesion with a long diameter >15 mm or an extranodal lesion with a long diameter >10 mm, diagnosed by PET-CT or CT imaging; (4) B-cell lymphoma patients must have tumor cells confirmed CD19 positive by immunohistochemistry; (5) Adequate vital organ function: liver function meeting: ALT ≤3×ULN, AST ≤3×ULN; serum creatinine ≤140 μmol/L; total bilirubin ≤2×ULN, or ≤3×ULN in patients with Gilbert's syndrome; hemodynamically stable as determined by echocardiography or multi-gated radionuclide angiography (MUGA) with left ventricular ejection fraction (LVEF) ≥45%; no active pulmonary infection, and percutaneous arterial oxygen saturation ≥92% without supplemental oxygen; (6) ECOG performance status: 0-2; (7) Expected survival of more than 3 months; (8) Female and male participants of childbearing potential must agree to use reliable and effective contraception from the time of signing the informed consent form until 2 years after receiving LCAR02 infusion (excluding natural family planning methods).
排除标准
- •(1) Patients who have experienced central nervous system diseases or pathological changes within 6 months before screening, including but not limited to: stroke, cerebrovascular accident, aneurysm, epilepsy, convulsions, aphasia, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar diseases, organic brain syndrome, or mental disorders.
- •(2) Patients with malignant tumors other than B-cell lymphoma. (3) Patients who received vaccines or B-cell targeted therapy within 4 weeks before screening.
- •(4) Patients with systemic autoimmune diseases or immunodeficiency. (5) Patients with grade 2-4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks before screening.
- •(6) Patients with relatively severe heart disease, such as angina, myocardial infarction, heart failure, or arrhythmia.
- •(7) Patients with a history of severe allergies to the drugs or excipients used in the clinical study or investigational drugs.
- •(8) Patients with active hepatitis B, HCV antibody positivity, HIV antibody positivity, or positive for syphilis.
- •(9) Patients with active infections requiring intravenous antibiotics or hospitalization.
- •(10) Pregnant or breastfeeding women.
研究组 & 干预措施
Anti CD19 Gene Therapy for B-cell Lymphoma
Experimental
干预措施: Anti-CD19 gene injection (Drug)
结局指标
主要结局
Adverse events
时间窗: up to 1 years
Total number, incidence and severity of adverse events (AEs) in patients of LCAR1901 infusion. The AEs will be assessed according to the 2019 Consensus on Cytokine Release Syndrome and Immune-cell-associated Neurotoxicity published by the American Society of Transplantation and Cell Therapy (ASTCT), the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and EBMT 2019 consensus.
The persistence, accumulation, and migration of anti-CD19 gene injection
时间窗: up to 1 years
Assessing the trafficking of anti-CD19 gene injection in the peripheral blood at the time of each infusion as well as at each time of follow-up by Quantitative Real-time Polymerase Chain Reaction or flow cytometry. Peripheral blood will be collected prior to the initial infusion and will be set as baseline.
次要结局
- Complete response (CR) rate(up to 1 year)
- Objective response rate (ORR)(up to 1 year)
- Duration of Response (DOR)(up to 1 year)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Anti CD19/BCMA CAR Gene Therapy for Autoimmune DiseasesNCT07121777Anhui Provincial Hospital18
招募中
不适用
Anti CD19/BCMA CAR Gene Therapy for Relapsed/Refractory Immune ThrombocytopeniaNCT06973356Anhui Provincial Hospital18
Unknown
1 期
Study of Safety and Efficacy of BZ019 in (R/R) Large B-cell LymphomaLarge B-cell LymphomaNCT04250324Shanghai Cell Therapy Group Co.,Ltd21
招募中
1 期
Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLENCT06892145Chongqing Precision Biotech Co., Ltd12
招募中
1 期
Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/Refractory B Cell LymphomaB Cell LymphomaNon Hodgkin LymphomaNCT06180174Chongqing Precision Biotech Co., Ltd24