Clinical Trial of Infusion of Activated NK Cells for the Treatment of Sarcomas

Inclusion Criteria:

1. Patients aged between 0 and 30 years diagnosed with malignant sarcoma, who at the endof conventional treatment still have detectable residual disease (based on imagingtechniques) or in case of stable disease or minimal disease when there is an absenceof clinical benefit from chemotherapy (poor tolerance due to adverse effects relatedto chemotherapy).
2. Lansky/Karnofsky index > 60%.
3. Mild-moderate (<4) organ functional impairment (hepatic, renal, respiratory),according to National Cancer Institute criteria (NCI CTCAE v5.0).
4. Left ventricular ejection fraction >39%.
5. Adult subjects who voluntarily signed informed consent prior to the first studyintervention.
6. Minor subjects whose representative/legal guardian voluntarily signed the informedconsent prior to the first intervention of the study.
7. In the case of mature minors (12 - 17 years of age), in addition to the consent signedby the legal guardian, the minor's assent will be obtained.
8. Women of childbearing capacity must have a negative pregnancy test at the time ofinclusion and must agree to use highly effective contraceptive methods (diaphragmsplus spermicide or male condom plus spermicide, oral contraceptive combined with asecond method of contraceptive implant, injectable contraceptive, permanentintrauterine device, sexual abstinence or partner with vasectomy) during theirparticipation in the study and within 30 days of the last visit.
9. Presence of a compatible haploidentical donor (father or mother or sibling).

Exclusion Criteria:

1. Patients with a history of poor therapeutic compliance.
2. Patients who, after a psycho-social evaluation, are censored as unsuitable for theprocedure.

• Socio-familial situation that makes proper participation in the study impossible.
• Patients with emotional or psychological problems secondary to the disease, suchas post-traumatic stress disorder, phobias, delirium, psychosis, requiringspecialist support.
• Evaluation of the involvement of family members in the patient's health.
• Impossibility to understand information about the trial.

3. Severe functional organ impairment (hepatic, renal, respiratory) (4), according to thecriteria of the National Cancer Institute (NCI CTCAE 5.0).
4. Contraindications, interactions, precautions for use and dose reductions indicated inthe corresponding data sheets must be considered.
5. Subjects who have been administered other investigational drugs in the 90 days priorto inclusion.