2023-506307-26-00招募中1 期
A Single-Arm, Open-Label, Multi-Centre, Phase Ib Study Evaluating the Safety and Preliminary Efficacy of AUTO1 in Pediatric Patients with CD19-Positive Relapsed/ Refractory (r/r) B cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B cell Non-Hodgkin Lymphoma (B NHL)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
To evaluate the safety and tolerability of AUTO1 in relapsed/refractory B-ALL and B-NHL
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female participants < 18 years old at screening
- •Patients with ≥6 kg body weight at screening
- •Willing and able to give written, informed consent to the current study (participant and/or parent or legal guardian).
- •Agreement to have a pregnancy test and use adequate contraception (if applicable).
- •Patients with diagnosis of: a. B ALL: r/r CD19-positive B ALL defined as one of the following: i. Primary refractory disease including: a) National Cancer Institute (NCI) high risk or Children’s Oncology Group (COG) high risk patients with MRD ≥ 0.1% EOI (end of induction) or > 0.01% at EOC (end of consolidation) as assessed by flow cytometry. b) COG intermediate risk cytogenetics with MRD ≥ 1% EOI as assessed by flow cytometry. c) COG good risk cytogenetics with ≥ 5% disease EOI as assessed. d) Down syndrome with MRD ≥ 0.01% EOC as assessed by flow cytometry. e) High risk infant ALL (MRD-positive disease as assessed by flow cytometry post induction and blinatumomab) ii. COG very high risk (VHR) first relapse if first remission ≤ 18 months. iii. Relapsed or refractory disease after two or more lines of systemic therapy. iv. Relapsed or refractory disease after allogeneic transplant provided AUTO1 infusion occurs ≥ 3 months after stem cell transplant. v. Any of the above with Philadelphia chromosome positive disease (Ph+ ALL) where patient is intolerant to or has failed at least one tyrosine kinase inhibitor (TKI) or if TKI therapy is contraindicated. OR b. B NHL: r/r CD19-positive aggressive mature B NHL defined as one of the following: i. Relapsed after one or more prior therapies (can include allogeneic and autologous hematopoietic stem cell transplant) ii. Primary refractory (have not achieved a CR or PR after the first line of therapy) with measurable disease by radiological criteria at screening including the following B NHL subtypes: i. Diffuse large B cell lymphoma (DLBCL) ii. Burkitt’s lymphoma (BL) iii. Primary mediastinal large B cell lymphoma (PMBCL) iv. High-grade B cell lymphoma not otherwise specified (NOS).
- •Karnofsky (age ≥ 10 years) or Lansky (age < 10 year) performance status score ≥ 50%.
- •In patients with B ALL, local documentation of CD19 expression on leukemic blasts in the BM, peripheral blood or cerebrospinal fluid (CSF), or biopsy, done no more than 30 days prior to consent. In patients treated with blinatumomab, testing should be undertaken after blinatumomab therapy has been stopped. In patients with mature B NHL, CD19 expression must be confirmed in a biopsy after any CD19 targeted therapies.
排除标准
- •Chronic myelogenous leukemia lymphoid in blast crisis.
- •History or presence of clinically relevant CNS pathology
- •Presence of CNS 3 disease or CNS 2 disease with neurological changes at screening
- •Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management.
- •History or presence of active or latent Hepatitis B virus or active Hepatitis C virus.
- •History of human immunodeficiency virus (HIV), human T cell lymphotropic virus (HTLV)-1, HTLV-2, or syphilis positive test.
- •Prior CD19 targeted therapy other than blinatumomab.
- •Patients who have experienced ≥ Grade 3 neurotoxicity following blinatumomab.
结局指标
主要结局
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
Incidence and duration of severe Hypogammaglobulinemia
Incidence and duration of severe Hypogammaglobulinemia
次要结局
- B-ALL Cohort: • Overall response rate (CR + CRi) • Proportion of patients achieving CR • Duration of remission (DoR); • Event free survival (EFS); • Proportion of patients achieving MRD-negative remission in BM; • Overall survival (OS); • Proportion of patients undergoing stem cell transplantation after AUTO1 infusion prior to relapse; • Incidence of CD19-negative relapse.
- B-NHL Cohort: • ORR (CR + PR) • Duration of response (DoR); • Progression free survival (PFS); • Overall survival (OS); • Incidence of CD19-negative relapse.
研究者
Wolfram Brugger
Scientific
Autolus Limited
研究点 (2)
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