NCT06097455尚未招募早期 1 期
First in Human, Pilot, Open-label, Prospective, Multicentre, Non-randomised Clinical Trial to Evaluate the Safety and Efficacy of ARI0003 (CART CD19/ CD269 Cells) in Patients With Relapsed/Refractory B-cell Aggressive Lymphoma
Fundacion Clinic per a la Recerca Biomédica8 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月15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
- 40
- 试验地点
- 8
- 主要终点
- Rate of > grade 3 CRS and/or ICANS
研究概览
简要总结
ths study consist in testing a CAR T therapy (ARI0003 cells (antiCD19 and antiBCMA) in patients suffering relapsed NHL (that means that symptoms of NHL reappeared ) or refractory (that means that they did not respond to other treatments). This is a first in human study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CD19+ or CD269+ relapsed/refractory (R/R) aggressive B-cell lymphoma in one of the following circumstances:
- •Burkitt's lymphoma;
- •Histology not covered by approved CART19-cell products (plasmablastic lymphoma, primary effusion lymphoma, intravascular lymphoma, transformed lymphoma from marginal zone lymphoma or chronic lymphocytic leukaemia, primary cutaneous DLBCL, T-cell rich DLBCL, high-grade B-cell lymphoma, grey zone lymphoma or grade 3b follicular lymphoma); or
- •Aggressive B-cell lymphoma that is refractory or relapsing after treatment with CART19-cell therapy.
- •Age older than 18 years.
- •ECOG performance status of 0-
- •Estimated life expectancy of at least 3 months.
- •Adequate venous access and absence of contraindications for lymphapheresis.
- •Signature of informed consent.
- •In patients who have received any anti-CD19 or anti-CD269 therapy (e.g. tisagenlecleucel, axicabtagene autoleucel, tafasitamab, loncastuximab, belantamab mafodotin, idecabtagene vicleucel, etc.), a centralised tumour sample confirming the expression of at least one of the antigens (either CD19 or CD269) will be needed at study inclusion
排除标准
- •Any experimental or non-commercialized therapy in the previous 4 weeks.
- •Any other concomitant neoplasia, unless it has been in complete remission for 3 years or longer, except for non-melanoma skin cancer or completely resected in situ carcinoma.
- •Active immunosuppressive therapy except for prednisone 10 mg/day (or equivalent).
- •Active infection requiring systemic medical therapy.
- •Active HBV or HCV infection.
- •Positive serology for HIV.
- •Any concomitant and uncontrolled medical disease.
- •Severe organic impairment defined by cardiac ejection fraction <40%, DLCO <40%, GFR <30 ml/min or bilirubin >3 times the upper limit of normality (unless due to Gilbert's syndrome).
- •Lactating or pregnant women.
- •Men or women of childbearing potential unable or unwilling to use highly efficient contraceptive measures from the beginning until the end of the study.
- •CNS disease in the form of a macroscopic solid lesion in the encephalon or spinal cord (isolated meningeal disease is allowed
结局指标
主要结局
Rate of > grade 3 CRS and/or ICANS
时间窗: in the first 30 days after ARI0003 administration
Rate of patients who develop grade \> 3 cytokine release syndrome (CRS) and/or grade \> 3 immune cell associated neurotoxicity syndrome (ICANS) according to the criteria and grading defined in the international consensus document of the American Society for Transplantation and Cellular Therapy (ASTCT criteria). ASTCT score can be between 1 and 4 (being 1 the minimum value and 4 the maximum) and where higher score means worse outcome.
ORR
时间窗: within 3 months post ARI0003 infusion
Overall response rate (ORR) according to Lugano criteria (best response within 3 months post ARI0003 infusion
次要结局
- Procedure-related mortality (PRM)(through study completion, an average of 24 months)
- Complete response rate(at 3 months)
- Progression-free survival(through study completion, an average of 24 months)
- Overall survival(through study completion, an average of 24 months)
- Toxicity: incidence of AE(at 3 and 12 months)
- Duration of response,(from month 3 to study completion, an average of 24 months)
研究者
研究点 (8)
Loading locations...
相似试验
Unknown
早期 1 期
CAR-T Cells in Treating Patients With Relapsed or Refractory Multiple MyelomaRelapsed or Refractory Multiple MyelomaNCT04626752Hebei Senlang Biotechnology Inc., Ltd.50
已完成
1 期
A Study to Evaluate the Tolerability, Safety, and Efficacy of an Anti-CD19 CAR-T Product in Patients With B-cell Lymphoproliferative DisordersNon-Hodgkin Lymphoma, B-cellAcute Lymphoblastic Leukemia ALLNCT06705530National Research Center for Hematology, Russia58
招募中
1 期
CD19-directed CAR-T Cell Therapy for R/R Acute Leukemia and LymphomaLeukemia, Acute LymphoblasticLymphoma, Non-HodgkinNCT06101381University of Sao Paulo81
已完成
1 期
Phase I Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and AdolescentsRelapsed Pediatric ALLRefractory Acute Lymphoblastic LeukemiaAcute Lymphoblastic LeukemiaNCT04888468Chongqing Precision Biotech Co., Ltd9
招募中
1 期
Autologous CD19 Car T-Cell Therapy For Severe Refractory Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematous (SLE)NCT06710717National University of Malaysia5