Infusion of activated NK cells for the treatment of children, adolescents and young adults with sarcomas.

Phase 1

• Conditions: Sarcoma; MedDRA version: 20.0Level: PTClassification code 10039491Term: SarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003578-42-ES
• Lead Sponsor: Antonio Pérez-Martínez

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-18
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Patients aged between 0 and 30 years diagnosed with malignant sarcoma, who continue to present detectable residual disease (based on imaging techniques) at the end of conventional treatment.

2. Lansky / Karnofsky Index> 60%.

3. Functional alteration of organs (liver, renal, respiratory) mild-moderate (<4), according to National Cancer Institute criteria (NCI CTCAE v4).

4. Left ventricular ejection fraction> 39%.

5. Adult subjects who have voluntarily signed informed consent prior to the first study intervention.

6. Minors whose legal representative / guardian has voluntarily signed informed consent prior to the first study intervention.

7. In the case of mature minors (12-17 years of age), in addition to the consent signed by the legal guardian, the child's consent will be obtained.

8. Women with reproductive capacity should have a negative pregnancy test at the time of inclusion and should be given access to highly effective contraceptive methods (diaphragms plus spermicide or male condom plus spermicide, oral contraceptive combined with a second method of contraceptive implantation , Injectable contraceptive, permanent intrauterine device, sexual abstinence or partner with vasectomy) during their participation in the study and within 30 days after the last visit.

9. Presence of a compatible haploident donor (parent or sibling).
Are the trial subjects under 18? yes
Number of subjects for this age range: 6
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Patients with a history of poor therapeutic compliance.

2. Patients who, after a psycho-social evaluation, are censored as unfit for the procedure:
• Socio-familial situation that makes it impossible to participate correctly in the study.
• Patients with emotional or psychological problems secondary to the disease such as posttraumatic stress disorder, phobias, delusions, psychosis, requiring specialist support.
• Evaluation of family involvement in the patient's health.
• Inability to understand test information.

3. Functional alteration of organs (severe hepatic, renal, respiratory) (4), according to the criteria of the National Cancer Institute (NCI CTCAE 4.3).

4. The contraindications, interactions, precautions for use and dose reductions indicated in the relevant technical data sheets should be considered.

5. Subjects who have been given other investigational drugs within 90 days prior to inclusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified