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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Natural Killer (NK) cells (a new immunotherapy)
Other interventionIt is proposed to infuse allogeneic NK cells from a haploidentical donor, after administration of lymphoablative chemotherapy and/or radiotherapy, as a treatment in patients with sarcomas, who have completed conventional treatment but maintain detectable residual disease. The administration of low doses of radiotherapy is aimed at stressing residual tumor cells by increasing the expression of NK cell activating receptor ligands. The administration of prior chemotherapy aims at immunosuppressing the patient, allowing immunotherapy with allogeneic NK cells from haploidentical donor as well as autologous NK cell recovery to lead the immune reconstitution after chemotherapy, prolonging the antitumor effect. In conjunction with NK cell infusion, low doses (1x106/UI/m2) of interleukin 2 (IL-2) will be administered subcutaneously every 48h for a maximum of 6 doses, to favor the expansion and antitumor effect of NK cells.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Allogeneic Natural Killer cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of allogeneic haploidentical adult differentiated Natural Killer cell infusion
Safety of infusion of allogeneic haploidentical adult differentiated Natural Killers cells in combination with inteleukin-2 after chemotherapy and radiotherapy. Each patient will be monitored for the detection of possible adverse effects. The Common Terminology Criteria for Adverse Events V5.0 will be followed and the proportion of patients with toxicity will be determined according to the degree of toxicity. The intensity of toxic effects that cannot be classified according to the criteria for toxicity of the aforementioned system will be classified as follows (MedDRA classification): (a) Mild (asymptomatic); b) Moderate (symptomatic but does not significantly interfere with function); c) Severe (causes significant interference with function); d) Life-threatening
Time frame
Through study completion, an average of 7 yearsSecondary outcomes
1
Disease progression
Disease progression rate after treatment with Natural Killer (NK) + Inteleukin-2 (IL-2) cells will be determined by imaging techniques.
Time frame
Five-year after treatment2
Infections (viral, fungal)
Incidence of episodes of infections (viral, fungal) and hospital admissions associated with treatment.
Time frame
Through study completion, an average of 7 years3
Expression levels of Natural Killer cell inhibitory/activating ligands
Expression levels of Natural Killer (NK) cell inhibitory/activating ligands in solid tumor samples and patient serum. These will be determined by immunohistochemistry and Polymerase Chain Reaction (PCR) techniques.
Time frame
Through study completion, an average of 7 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Antonio Pérez Martínez
Lead sponsor
Instituto de Investigación Hospital Universitario La Paz
Sponsor institution
Source ClinicalTrials.gov