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

NCT05304754 | Active Not Recruiting Phase 1

• 2 other identifiers: PHINK -01/20192019-000911-10
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 10

Brief 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

Conditions

High-risk Leukemias

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (TLD)

  To determine dose-limiting toxicity (TLD) of a single infusion of aloreactive NK cells or ex vivo IL-15-stimulated NK cells after haploTPH in pediatric patients with high-risk leukemias.

  52 weeks

• Maximum tolerated dose (MTD)

  To determine maximum tolerated dose (MTD) of a single infusion of aloreactive NK cells or ex vivo IL-15-stimulated NK cells after haploTPH in pediatric patients with high-risk leukemias.

  52 weeks

Secondary Outcomes (3)

• Efficacy of post haploTPH NK cell therapy

  Week 52

• Clinical evolution of patients

  Week 52

• Monitor immune reconstitution and characterize NK cells

  Week 52

Study Arms (2)

KIR mismatch aloreactive NK donor cells

ACTIVE COMPARATOR

Three patients from each cohort will receive NK aloreactive cells from a KIR mismatch donor

Biological: Alloreactive NK cells

NK cells stimulated ex vivo with IL-15 from KIR match donor

EXPERIMENTAL

Three patients in each cohort will receive ex vivo stimulated NK cells with IL-15 from a KIR match donor.

Biological: NK cells stimulated ex vivo with IL-15

Interventions

NK cells stimulated ex vivo with IL-15 BIOLOGICAL

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

NK cells stimulated ex vivo with IL-15 from KIR match donor

Alloreactive NK cells BIOLOGICAL

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

KIR mismatch aloreactive NK donor cells

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (10)

Hospital Clínico Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Infantil Universitario Niño Jeús

Madrid, 28009, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Regional Universitario de Málaga (Carlos de Haya)

Málaga, 29010, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Universitario La Fe

Valencia, 46026, Spain

Location

Related Publications (20)

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MeSH Terms

Interventions

Interleukin-15

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: March 31, 2022
• Study Start: November 30, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

ES (10)