2024-514052-32-00招募中1 期
Phase Ib, non-randomized, single-arm, open-label, single-center clinical trial to evaluate the safety of the first-in-human administration of the combination of dendritic cell (DC) immunization pulsed with tumor lysate and CAR-T cells targeting IL13Ra2 in patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG)
Fundacio Sant Joan De Deu1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年12月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of Grade 3–4 serious adverse events (SAEs) according to Common Toxicity Criteria (CTC) from the start of treatment (first administration of DCs) until the end of the study per patient.
研究概览
简要总结
To evaluate the safety of the first-in-human administration of a combination of dendritic cell (DC) immunisation (DIPG-DC) pulsed with lysates derived from a pool of 8 DIPG K27M-positive tumour cell lines (DIPG-lysate), together with intraventricular administration of anti-IL13Ra2 CAR-T cells (ARI0008), derived from T cells previously stimulated by DCs, in a cohort of patients with DIPG.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Fase Ib
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Written informed consent signed by the patient or legal representative and, if applicable, informed assent (for minors aged ≥12 years).
- •Candidates for placement of an Ommaya reservoir with intraventricular catheter.
- •Fertile males and females must use a highly effective contraceptive method.
- •Newly diagnosed DIPG based on clinical-radiological criteria and/or histological and molecular confirmation. Biopsied patients must show K27M mutation. Clinical and radiological criteria will be assessed by the PI with support from a neuroradiologist at Hospital Sant Joan de Déu.
- •Prior neoadjuvant radiotherapy (standard of care for DIPG) before receiving the trial treatment. Radiotherapy defined as 54–60 Gy in 1.8–2.2 Gy/fraction.
- •Age between 3 and 24 years inclusive.
- •Lansky performance score ≥50%. For patients ≥16 years, Karnofsky score ≥50%.
- •Life expectancy greater than 12 weeks.
- •Preserved bone marrow function: absolute neutrophil count >1,000/mcL, platelets >100,000/mcL (independent of transfusions), haemoglobin >8 g/dL (may be transfusion-dependent).
- •Normal liver and kidney function.
- •Adequate venous access for leukapheresis.
排除标准
- •Patients with disease progression or disseminated disease on MRI at diagnosis.
- •HIV+, HCV+, HBV+ patients or those not meeting the serological screening criteria described in Annex
- •Breastfeeding.
- •Participation in another experimental study within the last 3 months.
- •Patients receiving other antitumor treatments. If previously treated, a washout period of at least 4 weeks is required.
- •Associated comorbidities that, in the investigator’s clinical judgement, cannot be adequately controlled and may compromise the patient’s ability to tolerate the study treatment.
- •Patients with neoplasms other than DIPG.
- •Patients requiring corticosteroid treatment at a daily dose >2 mg/day dexamethasone (or equivalent).
- •Patients for whom corticosteroid treatment cannot be suspended during the week prior to leukapheresis.
- •Patients receiving bevacizumab for pseudoprogression who do not show neurological stability.
- •Patients with uncontrolled infections.
结局指标
主要结局
Number of Grade 3–4 serious adverse events (SAEs) according to Common Toxicity Criteria (CTC) from the start of treatment (first administration of DCs) until the end of the study per patient.
Number of Grade 3–4 serious adverse events (SAEs) according to Common Toxicity Criteria (CTC) from the start of treatment (first administration of DCs) until the end of the study per patient.
次要结局
- Proportion of patients with adverse events (AEs) and serious adverse events (SAEs), as well as the proportion of patients who discontinue treatment due to AEs.
- Percentage of patients receiving the full treatment regimen, defined as the complete administration of both DCs and CAR-T cells.
- Evaluation of immunological parameters according to the study schedule.
- Overall survival (OS) and progression-free survival (PFS) in DIPG patients treated with the proposed regimen. A comparison will be made with historical controls from the institution (HSJD) and other international institutions (COG and SIOP).
- Evaluation of radiological changes following RAPNO criteria (see Annex 3: Criteria for Radiological and Clinical Response Assessment).
- Evaluation of the distribution of anti-IL13Ra2 CAR-T cells in CSF, peripheral blood, and, if available, tumour samples, according to the study schedule.
- Correlation between histological and molecular characterisation, clinical-radiological response, and cellular response generated in peripheral blood and CSF following treatment.
- Correlation between immunological response and clinical progression. Determination of whether cellular response in peripheral blood and CSF correlates with increased overall survival and progression-free survival.
- Evaluation of performance (QoL) as an indicator of quality of life. QoL will be assessed through prospective evaluation of each patient’s functionality using the PedsQL questionnaire (see Annex 2: Neurological and Functional Assessment).
研究者
Andrés Morales La Madrid
Scientific
Fundacio Sant Joan De Deu
研究点 (1)
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