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 Paz0 个研究点目标入组 10 人开始时间: 2024年4月9日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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).

•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.

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