NCT05032599终止1 期
First-in-Human (FIH), Open-Label, Non-Randomized, Single-Arm Phase 1 Study to Evaluate the Safety and Tolerability of Donor-Derived CD5 CAR T Cells in Subjects with Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events (AE)
研究概览
简要总结
This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and tolerability of CD5 CAR T cells in subjects with relapsed or refractory T-cell acute lymphoblastic leukemia. At least 18 subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be administrated for 3 days.
Then this study will be using BOIN1/2 approach from starting dose 1: 1×10^6 (±20%) to dose 2: 2×10^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10^5 (±20%) /kg.
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
- 1 Year 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Candidates with relapse or refractory CD5+ T cell acute lymphoblastic leukemia, who have progressed on after treatment with all standard therapies or intolerant of standard care, have limited prognosis with currently available therapies and had no available curative treatment options (such as SCT or chemotherapy)
- •Male or female, aged 1-70 years
- •No serious allergic constitution
- •Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2
- •Have life expectancy of at least 60 days based on investigator's judgement
- •CD5 positive in bone marrow or cerebrospinal fluid (CSF) by flow cytometry, or CD5 positive in tumor tissues by immunohistochemistry; (CD5 positive criteria: Flow cytometry: Positive: > 80% of tumor cells expressed CD5 and the MFI of CD5 is the same as that in normal T cells; Dim: > 80% of tumor cells expressed CD5, but the MFI of CD5 is lower than that in normal T cells as least as 1log; Partial positive: 20-80% of tumor cells expressed CD5 and the MFI of CD5 is the same as that in normal T cells. tumor tissue immunohistochemistry: Positive > 30% tumor cells expressed CD5);
- •Provide a signed informed consent before any screening procedure; subjects who voluntarily participate in the study should have the ability to understand and sign the informed consent form and be willing to follow the study visit schedule and relevant study procedure, as specified in the protocol. Candidates aged 19-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form; Children candidates of 8-18 years old need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form and their legal guardian or patient advocate has also need to sign the treatment consent form and voluntary consent form, respectively.Children candidates of 1-7 can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form.
- •Have suitable and available allogeneic hematopoietic stem cell transplantation donor, and is willing to proceed to SCT if achieve CR.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Intracranial hypertension or disorder of consciousness
- •Symptomatic heart failure or severe arrhythmia
- •Symptoms of severe respiratory failure
- •Complicated with other types of malignant tumors
- •Diffuse intravascular coagulation
- •Serum creatinine and / or blood urea nitrogen ≥ 1.5 times of the normal value
- •Suffering from septicemia or other uncontrollable infections
- •Patients with uncontrollable diabetes
- •Severe mental disorders
- •Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI)
- •Have received organ transplantation (excluding bone marrow transplant)
- •Reproductive-aged female patients with positive blood HCG test
- •Screened to be positive of infection of hepatitis (including hepatitis B and C), AIDS or syphilis
- •Post-CAR SCT is not feasible in patients who plan to receive new-donor derived CD5 CAR T cells
- •No donor is applicable for peripheral blood mononuclear cell (PBMC) collection or no frozen donor's PBMC is available for manufacturing CAR T cells.
研究组 & 干预措施
CD5 CART
Experimental
All patients who receive CD5 CART cell infusion
干预措施: CD5 CART (Biological)
结局指标
主要结局
Incidence and severity of adverse events (AE)
时间窗: 30 days post intravenous injection
Incidence and type of dose-limiting toxicity (DLT)
时间窗: 21 days post intravenous injection
次要结局
- Best overall response (BOR)(3 months post infusion)
- Objective response rate (ORR)(30 days post infusion)
- Quantification of CAR T cells(2 years post infusion)
- Severe adverse events (SAE)(2 years post infusion)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
1 期
Safety and Efficacy Study of CI-135 CAR-T Cells in Subjects with Relapsed or Refractory Acute Myeloid LeukemiaAcute Myeloid LeukemiaNCT05266950Beijing Boren Hospital7
撤回
1 期
Donor-Derived CD5 CAR T (CT125B) Cells for Relapsed or Refractory T- Cell Acute Lymphoblastic Leukemia/LymphomaT-Cell Acute Lymphoblastic Leukemia/LymphomaNCT05487495Beijing Boren Hospital18
招募中
1 期
A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1106 in Advanced Solid TumorsSolid TumorsNCT05650242Shandong Boan Biotechnology Co., Ltd177
进行中（未招募）
1 期
A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid TumoursRenal Cell CarcinomaMetastatic Colorectal CarcinomaHead and Neck Squamous Cell CarcinomaPancreatic Ductal AdenocarcinomaNon-small Cell Lung CancerGastric CancerNon-small Cell Lung CancerNCT06147037AstraZeneca13
已完成
1 期
A First-in-human Clinical Evaluation of SN132D in Patients With Breast and Pancreatic CancerPancreas CancerBreast CancerNCT04080024Spago Nanomedical AB14