Clinical trial · Interventional
"Phase I / II Study on Infusion of Natural Killer Cells After Haploidentical Transplantation in Pediatric Patients"
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 Hematological Neoplasms
NCT05304754CI-TRIAL-00088188PHINKactive not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High-risk Leukemias | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alloreactive NK cells | Biological | — | UNRESOLVED |
| NK cells stimulated ex vivo with IL-15 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- KIR mismatch aloreactive NK donor cells
- description
- Three patients from each cohort will receive NK aloreactive cells from a KIR mismatch donor
- interventionNames
- Biological: Alloreactive NK cells
- type
- EXPERIMENTAL
- label
- NK cells stimulated ex vivo with IL-15 from KIR match donor
- description
- Three patients in each cohort will receive ex vivo stimulated NK cells with IL-15 from a KIR match donor.
- interventionNames
- Biological: NK cells stimulated ex vivo with IL-15
Primary outcomes (2)
- measure
- Dose-limiting toxicity (TLD)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (20)
- BACKGROUNDCiceri F, Labopin M, Aversa F, Rowe JM, Bunjes D, Lewalle P, Nagler A, Di Bartolomeo P, Lacerda JF, Lupo Stanghellini MT, Polge E, Frassoni F, Martelli MF, Rocha V; Acute Leukemia Working Party (ALWP) of European Blood and Marrow Transplant (EBMT) Group. A survey of fully haploidentical hematopoietic stem cell transplantation in adults with high-risk acute leukemia: a risk factor analysis of outcomes for patients in remission at transplantation. Blood. 2008 Nov 1;112(9):3574-81. doi: 10.1182/blood-2008-02-140095. Epub 2008 Jul 7. PMID 18606875
- BACKGROUNDRuggeri L, Capanni M, Urbani E, Perruccio K, Shlomchik WD, Tosti A, Posati S, Rogaia D, Frassoni F, Aversa F, Martelli MF, Velardi A. Effectiveness of donor natural killer cell alloreactivity in mismatched hematopoietic transplants. Science. 2002 Mar 15;295(5562):2097-100. doi: 10.1126/science.1068440. PMID 11896281
- BACKGROUNDLeung W, Iyengar R, Triplett B, Turner V, Behm FG, Holladay MS, Houston J, Handgretinger R. Comparison of killer Ig-like receptor genotyping and phenotyping for selection of allogeneic blood stem cell donors. J Immunol. 2005 May 15;174(10):6540-5. doi: 10.4049/jimmunol.174.10.6540. PMID 15879158
- BACKGROUNDAversa F. Haploidentical haematopoietic stem cell transplantation for acute leukaemia in adults: experience in Europe and the United States. Bone Marrow Transplant. 2008 Mar;41(5):473-81. doi: 10.1038/sj.bmt.1705966. Epub 2008 Jan 7. PMID 18176612
- BACKGROUNDLang P, Handgretinger R. Haploidentical SCT in children: an update and future perspectives. Bone Marrow Transplant. 2008 Oct;42 Suppl 2:S54-9. doi: 10.1038/bmt.2008.285. PMID 18978746
- BACKGROUNDLeung W, Campana D, Yang J, Pei D, Coustan-Smith E, Gan K, Rubnitz JE, Sandlund JT, Ribeiro RC, Srinivasan A, Hartford C, Triplett BM, Dallas M, Pillai A, Handgretinger R, Laver JH, Pui CH. High success rate of hematopoietic cell transplantation regardless of donor source in children with very high-risk leukemia. Blood. 2011 Jul 14;118(2):223-30. doi: 10.1182/blood-2011-01-333070. Epub 2011 May 25.