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

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.

Trial Details

NCT ID
NCT05952310
Phase
NA
Sponsor
Antonio Pérez Martínez
Status
RECRUITING
Cancer Type
Sarcoma
Interventions
  • Natural Killer (NK) cells (a new immunotherapy)
Locations (sample)
  • Madrid, Spain|40.4165,-3.70256

Key Eligibility Criteria

  • Patients aged between 0 and 30 years diagnosed with malignant sarcoma, who at the end of conventional treatment still have detectable residual dise…
  • 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%.

For full eligibility, visit ClinicalTrials.gov.

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