2024-513431-25-00招募中2 期
Phase I / II Clinical Trial, multicenter, open, of infusion of activated NK cells for the treatment of children, adolescents and young adults with sarcomas.
Hospital Universitario La Paz, Hospital Universitario La Paz1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年4月18日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Toxicity will be classified according to the common toxicity criteria established by the National Cancer Institute (CTC NCI, version 5.0).
研究概览
简要总结
To evaluate the safety of immunotherapy with haploidentical allogeneic NK cells together with IL-2 after lymphoablative chemotherapy and/or low-dose radiotherapy in pediatric, adolescent and young adult patients with refractory sarcoma.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Phase I / II Clinical Trial, multicenter, open
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients aged 0-40 years diagnosed with malignant sarcoma, who at the end of conventional treatment still have detectable residual disease (based on imaging techniques) or in case of stable disease or minimal disease when there is an absence of clinical benefit from chemotherapy (poor tolerance due to adverse effects related to chemotherapy).
- •Lansky/Karnofsky index > 60%.
- •Mild-moderate (<4) organ functional impairment (hepatic, renal, respiratory), according to National Cancer Institute criteria (NCI CTCAE v5.0).
- •Left ventricular ejection fraction >39%.
- •Adult subjects who had voluntarily signed the informed consent prior to the first intervention of the study.
- •Minor subjects whose representative/legal guardian voluntarily signed the informed consent prior to the first intervention of the study.
- •In the case of mature minors (12 - 17 years of age), in addition to the consent signed by the legal guardian, the minor's assent will be obtained.
- •Women of childbearing capacity must have a negative pregnancy test at inclusion and must agree to use highly effective contraceptive methods (diaphragms plus spermicide or male condom plus spermicide, oral contraceptive combined with a second method of contraceptive implant, injectable contraceptive, permanent intrauterine device, sexual abstinence or vasectomized partner) during their participation in the study and within 30 days of the last visit.
- •Presence of a compatible haploidentical donor (parent or sibling).
排除标准
- •Patients with a history of poor therapeutic compliance.
- •Patients who after a psycho-social evaluation are censored as unsuitable for the procedure. Socio-familial situation that makes proper participation in the study impossible. Patients with emotional or psychological problems secondary to the disease, such as post-traumatic stress disorder, phobias, delirium, psychosis, requiring specialist support. Evaluation of the involvement of family members in the patient's health. Impossibility to understand information about the trial.
- •Severe functional organ impairment (hepatic, renal, respiratory) (4), according to the criteria of the National Cancer Institute (NCI CTCAE 5.0).
- •The contraindications, interactions, precautions for use and dose reductions indicated in the corresponding data sheets should be considered.
- •Subjects who have been administered other investigational drugs in the 90 days prior to inclusion.
结局指标
主要结局
Toxicity will be classified according to the common toxicity criteria established by the National Cancer Institute (CTC NCI, version 5.0).
Toxicity will be classified according to the common toxicity criteria established by the National Cancer Institute (CTC NCI, version 5.0).
次要结局
- Incidence of episodes of febrile neutropenia, bacteraemia, infections (viral, fungal), haematological recovery and hospital admission associated with treatment.
- Five-year disease progression rate after treatment with NK cells + IL-2. This will be determined by imaging techniques.
- Expression levels of NK cell inhibitory/activating ligands in solid tumour samples and patient serum. These shall be determined by immunohistochemistry and PCR techniques.
研究者
Antonio Pérez Martínez
Scientific
Hospital Universitario La Paz
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or Refractory B-cell Non-Hodgkin LymphomaNCT07283679M.D. Anderson Cancer Center30
招募中
2 期
A study to understand the safety and benefit of AlloNK® with rituximab in patients with hard-to-treat rheumatic diseases2025-520461-41-00Artiva Biotherapeutics Inc.48
进行中（未招募）
1 期
Exploratory Clinical Study on Memory NK Cell Therapy for Advanced Metastatic Solid TumorsNCT07274449The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School6
已完成
1 期
An Autologous NK/CIK Cell Product (PB101) in Combination With EGFR-TKI for Treating Lung CancerNon-small Cell Lung CancerNCT07271446Precision Biotech Taiwan Corp.8
招募中
1 期
Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRCNCT07281716Dan Feng24