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Clinical Trials in Spain / NCT05304754
Active, not recruiting Phase 1/2

"Phase I / II Study on Infusion of Natural Killer Cells After Haploidentical Transplantation in Pediatric Patients"

NCT05304754 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1/2
Started
2020-11-30
Last updated
2025-04-06

Condition(s) studied

High-risk Leukemias

Investigational drug(s) / intervention(s)

NK cells stimulated ex vivo with IL-15Alloreactive NK cells

NK cells stimulated ex vivo with IL-15: When patient and donor are KIR-HLA match, the patient submits all HLA class I molecules, or in the absence of any, your donor does not have this molecule, or having it lacks the corresponding KIR receiver. For more information detailed information on the product under investigation, reference is made to the Dossier of the Research Product (IMPD): PEI 09-008

Alloreactive NK cells: When the patient lacks the HLA class I molecule and his donor has this molecule and also the donor NK cells have the KIR receptor that recognizes the absence of the corresponding HLA class I ligand

Study summary

Phase I / II study on infusion of alloreactive or stimulated Natural Killer cells with IL-15 ex vivo after haploidentical transplantation of hematopoietic progenitors in pediatric patients with hematologic malignancies (PHINK

Eligibility

Sex
ALL
Min age
—
Max age
21 Years
Healthy volunteers
No
Inclusion Criteria: * Patients of both sexes with age ≤ 21 years. * Not having an identical HLA donor (family or non-family) available in the time needed for the donation of hematopoietic parents. * Having a haploidenic donor available * Diagnosis of high-risk hematological malignancy. This includes: * i. High risk ALL in first complete remission (RC1); * ii. ALL in second complete remission (RC2); * iii. ALL in third complete remission (RC3) or later; * iv. High risk AML in RC1; * v. AML in RC2 or later; * vi. Relapsed AML with \<25% blasts in bone marrow; * vii. AML related to previous treatments in CR\> 12 months; * viii. Primary or secondary myelodysplastic syndrome * ix. NK cell leukemia, biphenotypic or undifferentiated in RC1 or later, * x. Chronic myeloid leukemia (CML) in accelerated phase, in chronic phase with persistent molecular positivity, or with intolerance to tyrosine kinase inhibitors * xi. Hodgkin's lymphoma in RC2 or later after failure of autologous TPH, or unable to mobilize hematopoietic progenitors for autologous TPH * xii. Non-Hodgkin's lymphoma in RC2 or later after failure of autologous TPH, or unable to mobilize hematopoietic progenitors for autologous TPH * xiii. Myelomonocytic juvenile leukemia. * Positive pre-transplant evaluation * i. Left ventricular ejection fraction \> 40% or shortening fraction ≥ 25%; * ii. Creatinine clearance (ACr) or glomerular filtration rate (TFG) ≥ 50 ml/min/1.73 m2 * iii. Forced Vital Capacity (FVC) ≥ 50% of predicted value or pulse-oximetry ≥ 92% if the patient cannot perform the pulmonary function tests; * iv. Karnofsky or Lansky Index (depending on the patient's age) ≥ 50; * v. Bilirubin ≤ 3 times the upper limit of normal for age * vi. Alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal for age * vii. Women who are not breastfeeding. * viii. No uncontrolled bacterial, fungal, or viral infections at the time of inclusion. * Women of childbearing potential must have a negative serum or urine pregnancy test performed within 14 days prior to trial inclusion and must agree to use highly effective contraceptive methods (diaphragms plus spermicide or male condom plus spermicide, oral contraceptive combined with a second method of contraceptive implant, injectable contraceptive, permanent intrauterine device, sexual abstinence, or partner with vasectomy) during study participation and for six months after the last trial visit. In the case of male patients with reproductive capacity, they must commit to using an appropriate barrier method for the duration of the study and for up to 6 months thereafter Exclusion Criteria: * Patients with an active infectious process or other serious underlying medical condition * Patients who, according to the investigator's criteria, have a history of poor compliance with therapy. * Patients who after a psycho-social evaluation are advised as not suitable for the procedure: * i. Social-family situation that makes correct participation in the study impossible. * ii. Patients with emotional or psychological problems secondary to the illness such as post-traumatic stress disorder, phobias, delusions, psychosis, with the need for support from specialists. * iii. Evaluation of the involvement of family members in the health of the patient * Inability to understand the information about the trial * Received an investigational drug within 30 days prior to the start of therapy or within 5 half-lives of receiving an investigational drug, whichever is longer.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Hospital Clínico Universitario de Santiago Santiago de Compostela A Coruña
Hospital Universitario Central de Asturias Oviedo Principality of Asturias
Hospital de la Santa Creu i Sant Pau Barcelona Spain
Hospital General Universitario Gregorio Marañón Madrid Spain
Hospital Infantil Universitario Niño Jeús Madrid Spain
Hospital Universitario La Paz Madrid Spain
Hospital Regional Universitario de Málaga (Carlos de Haya) Málaga Spain
Hospital Clínico Universitario Virgen de la Arrixaca Murcia Spain
Hospital Universitario Virgen del Rocío Seville Spain
Hospital Universitario La Fe Valencia Spain

More Instituto de Investigación Hospital Universitario La Paz trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05304754 on ClinicalTrials.gov ↗ ← All trials in Spain