NCT05648019招募中2 期
CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol
KK Women's and Children's Hospital4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年3月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Protocol Feasibility
研究概览
简要总结
The purpose of this study is to describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed/ refractory B-lineage leukaemia/ lymphoma.
详细描述
This is a single arm, open-label, multi-center, phase II feasibility study to deliver point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed / refractory B-lineage leukaemia / lymphoma.
The study consists of the following phases:
- Screening phase: Eligibility; enrolment
- Preparatory phase: Bridging therapy (if required); leukapheresis; CAR T manufacturing; lymphodepletion.
- Treatment phase: Infusion of single dose of anti-CD19 CAR T-cells
- Follow-up Phase: Efficacy and safety monitoring up to 24 months
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
- 0 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible disease conditions:
- •Relapsed or refractory B-cell ALL (all must be satisfied)
- •Presence of lymphoblasts in bone marrow aspirate by morphologic assessment or positive minimal residual disease at screening.
- •Relapsed or refractory or ineligible for HSCT
- •For relapsed B-ALL: Documentation of CD19 tumour expression (e.g. by flow cytometry) demonstrated in bone marrow or peripheral blood within 3 months of study entry
- •Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
- •Age at screening:
- •< 18 years (paediatric group); or
- •≥ 18 years (adult group)
- •Adequate organ functions:
- •Life expectancy more than 12 weeks.
- •Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) performance status ≥ 50 at screening.
- •Must meet the institutional criteria to undergo leukapheresis or have a leukapheresis product of non-mobilized cells received and accepted by the manufacturing site.
排除标准
- •Patients with any of the following will be excluded:
- •B-ALL with isolated extramedullary disease relapse
- •Patients with concomitant genetic syndrome: such as patients with Fanconi anaemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome will not be excluded.
- •Patients with Burkitt's lymphoma/leukaemia (i.e. patients with mature B-cell ALL; leukaemia with B-cell [sIg positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation)
- •Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening
- •Human Immunodeficiency Virus (HIV) positive test within 8 weeks of screening
- •Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD)
- •Active CNS involvement by malignancy, defined by CNS-3 per NCCN guidelines. Subjects with CNS-2 involvement or with history of CNS disease that have been actively treated are eligible.
- •Patient has an investigational medicinal product within the last 30 days prior to screening.
- •Pregnant or nursing women.
- •Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants, unless they are using highly effective methods of contraception for a period of 1 year after the CAR T-cell infusion. All female patients of childbearing potential must have a negative pregnancy test performed within 48 hours before infusion of CAR T-cells.
- •The following are not strictly exclusion criteria but must be discussed with PI/Site-PI:
- •Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
- •Treatment with any prior gene therapy product
- •Has had treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy
结局指标
主要结局
Protocol Feasibility
时间窗: 3 years
To describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed / refractory B-lineage leukaemia / lymphoma by assessing number and percentage of enrolled patients who have successful manufacturing of CAR T-cell product, and number and percentage of enrolled patients who go on to receive the CAR T-cell product.
次要结局
- Overall Response Rate(6 months)
- Toxicity Evaluations(6 months)
研究者
研究点 (4)
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