NCT07300683招募中1 期
Fratricide-Resistant Autologous Chimeric Antigen Receptor T Cells Targeting CCR9 for the Treatment of T Cell Acute Lymphoblastic Leukaemia/ Lymphoma
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Feasibility of generation of CARCCR9 T cells as evaluated by the number of therapeutic products generated.
研究概览
简要总结
The goal of this clinical trial is to learn if anti-CCR9 CAR T cells (which will be made using the patient's own blood cells) are safe and which dose should be used in children and adults with T cell leukaemia and lymphoma.
Participants will:
- have T cells collected from their blood and these T cells will be used to make the CAR-T cells in a specialized laboratory.
- be admitted at the hospital a week before the CAR T cells infusion to receive a short course of chemotherapy drugs which prepare the body to receive the CAR T cells.
- be given the CAR T cells into their vein.
- stay in the hospital for a minimum of 2 weeks to be closely monitored
- following discharge, participants will come to the clinic for check-ups (approximately 12 visits in the first two years)
- during screening, treatment and follow up visits, participants will have physical examination, collection of blood samples and bone marrow biopsies and/or imaging tests (CT/PET-CT scans) depending on their type of T-cell cancer.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory T-ALL/T-LBL following at least one (≥18 years old) or two (<18 years old) standard prior lines of combination cytotoxic therapy
- •CCR9-positive disease as assessed by flow cytometry
- •T-LBL patients only: Patients must have measurable disease
- •Agreement to have a pregnancy test, use adequate contraception (if applicable)
- •Written informed consent
排除标准
- •ECOG performance score >2 (patients aged ≥10 years old) OR Lanksy score ≤50% (patients aged <10 years old)
- •Stem Cell Transplant patients only: active significant acute GvHD or moderate/severe chronic GvHD requiring immunosuppressive therapy and/or systemic steroids
- •Active CNS involvement of disease
- •Active hepatitis B, C or HIV infection
- •Oxygen saturation ≤90% on air
- •Bilirubin >3 x upper limit of normal
- •GFR <30 ml/min
- •Cardiac dysfunction
- •Patients receiving corticosteroids at a supraphysiological dose that cannot be discontinued
- •Known allergy to any component of the ATIMP
- •Any contraindications to lymphodepletion or to the use of cyclophosphamide or fludarabine as per local SmPC
- •Women who are pregnant or breastfeeding
- •Life expectancy <3 months
- •Fulminant or rapidly progressive disease
研究组 & 干预措施
Autologous anti-CCR9 CAR T cells
Experimental
Patients will receive autologous anti-CCR9 CAR T cells intravenously.
干预措施: CARCCR9 T cells (Biological)
结局指标
主要结局
Feasibility of generation of CARCCR9 T cells as evaluated by the number of therapeutic products generated.
时间窗: 2 years
To determine the feasibility of semi-automated autologous CARCCR9 T cells manufacture in patients with r/r T-ALL/T-LBL, in the setting of a Phase I trial.
Incidence of treatment-related adverse events (safety and tolerability)
时间窗: From CAR T cells infusion until 28 days post infusion
Incidence of grade 3-5 toxicity causally related to the ATIMP.
次要结局
- Persistence of CARCCR9 T cells(From CAR T cells infusion until 2 years post infusion)
- Expansion of CARCCR9 T cells(From CAR T cells infusion until 2 years post infusion)
- Potential efficacy of CARCCR9 T cells(At 1 and 2 years post CAR T cells infusion)
- Time to disease progression(From CAR T cells infusion (Day 0) until the date of first documented progression, assessed up to 15 years post CAR T cells infusion.)
- Event free survival(From CAR T cells infusion (Day 0) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 years post CAR T cells infusion.)
- Overall survival(From CAR T cells infusion (Day 0) until the date of death from any cause, assessed up to 15 years post CAR T cells infusion.)
研究者
研究点 (1)
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