Safety and efficacy of hCD1a-CAR T (OC-1) therapy, in patients with relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LL)_CARxALL
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of adverse events grade III-IV using Common Toxicity Criteria for Adverse Events (CTCAE) version 5.
研究概览
简要总结
To assess the safety of OC-1 in patients with primary relapsed/refractory CD1a-positive T-ALL/LL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- First in humans, exploratory, open-label, single-arm, multicentre, non-competitive, dose escalation
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Children older than 2 years or adults, male and female in both groups.
- •Patients CD1a antigen blast expression ≥20% at inclusion, either immunophenotypically (flow cytometry) or histologically confirmed.
- •R/R CD1a-positive T-ALL/LL patients, including morphologic or MRD-detectable (≥1x10-4) bone marrow and/or extramedullary relapses after 2 therapy lines: Relapse after allogeneic haematopoietic stem cell transplantation (allo-HSCT) Primary refractoriness, defined as either morphologic persistence or detectable MRD (≥1x10-4) after two standard therapy lines, making the patient not candidate for allo-HSCT. Refractory first relapse. Second or further relapse.
- •Patient without reproductive capacity or else, commitment to the use of a highly effective method of contraception during the study.
排除标准
- •Limiting organ dysfunction, such as uncontrolled cardiac (e.g., depressed left ventricular ejection fraction (LVEF), <45%), pulmonary, liver, renal or CNS dysfunction.
- •Other non-controlled concomitant neoplasms.
- •Allo-HSCT within a time frame <3 months, or requiring continued immunosuppressive treatment for graft versus host disease (GvHD).
- •Uncontrolled epilepsy or underlying central nervous system (CNS) severe disease.
- •Active bacterial, fungal or viral infection not controlled by adequate treatment.
- •Known HIV, active hepatitis B (HBV), or hepatitis C virus (HCV) infection.
- •Women who are pregnant (urine/blood pregnancy test positive) or lactating.
- •Severe illness or medical condition, which would not permit the patient to be managed according to the protocol.
- •Suffering from a serious autoimmune disease or immunodeficiency disease
- •The patient participated in other experimental drug clinical trial within 6 weeks prior to OC-1 infusion.
结局指标
主要结局
Number of adverse events grade III-IV using Common Toxicity Criteria for Adverse Events (CTCAE) version 5.
Number of adverse events grade III-IV using Common Toxicity Criteria for Adverse Events (CTCAE) version 5.
Incidence of severe Cytokine release syndrome (CRS) # grade III and Immune effector cell-associated neurotoxicity syndrome (ICANS) # grade II
Incidence of severe Cytokine release syndrome (CRS) # grade III and Immune effector cell-associated neurotoxicity syndrome (ICANS) # grade II
Proportion of patients with non-relapse, treatment-related mortality (NRM)
Proportion of patients with non-relapse, treatment-related mortality (NRM)
Number of adverse events of special interest (AESI)
Number of adverse events of special interest (AESI)
Assessment of the immunological homeostasis, through the description of lymphocytes subpopulations at each study timepoint.
Assessment of the immunological homeostasis, through the description of lymphocytes subpopulations at each study timepoint.
Incidence of severe (#3) treatment-related dermatological events.
Incidence of severe (#3) treatment-related dermatological events.
Number of patients developing dose limiting toxicity (DLT)
Number of patients developing dose limiting toxicity (DLT)
次要结局
- Remission rate: Percentage of patients presenting complete response (CR) or incomplete count recovery (CRi) at any point after treatment
- Duration of remission: The duration of the remission will be assessed from the first documented date of remission status until progression (in days)
- Minimal residual disease (MRD) response by flow cytometry: blast count among patients presenting bone marrow complete response (sensitivity 10-4).
- Progression-free survival: time since the first infusion to the documented loss of response. In patients not presenting a CR or CRi progression free survival will be zero
- Overall survival time since first infusion to date of death
- Persistence of OC-1, as determined by flow cytometry and quantitative analysis by qPCR
研究者
Medical Department
Scientific
Onechain Immunotherapeutics S.L.