Clinical Trial of Infusion of Activated NK Cells for the Treatment of Sarcomas
ConditionMalignant Sarcoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 30
SponsorAntonio Pérez Martínez
About this trial
This is an exploratory therapeutic study (according to the terminology of the "ICH Harmonised Tripartite Guideline Topic E8. General Considerations for Clinical Trials". EMEA, March 1998. CPMP/ICH/291/95), open-label, non-randomized, multicenter study. It is considered phase I/II since the safety and efficacy of the infusion of allogeneic haploidentical NK cells in combination with chemotherapy and/or radiotherapy in the treatment of pediatric, adolescent and young adult patients with refractory sarcoma will be sought.
Eligibility criteria
Qualifiers
Patients aged between 0 and 30 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%.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Natural Killer (NK) cells (a new immunotherapy)
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Antonio Pérez Martínez
Lead sponsor
Instituto de Investigación Hospital Universitario La Paz
Sponsor institution
Source ClinicalTrials.gov