Health Trials

Phase I Clinical Trial of ThINKK Adoptive Immunotherapy After Allogeneic Hematopoietic Transplantation in Children With Leukemia or Neuroblastoma

ConditionsLeukaemia (Acute Lymphoblastic)Leukaemia (Acute Myeloid)NeuroblastomaNeuroblastoma, MetastaticLeukaemia, Lymphoblastic, AcuteLeukemia Acute MyeloidLeukemia (Both ALL and AML)Leukemia Acute Myeloid - AMLHematopoetic Stem Cell TransplantationHematopoetic Stem Cell Transplant
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2-12
SponsorMichel Duval

About this trial

A first-in-class adoptive immunotherapy we called ThINKK, for Therapeutic Inducers of Natural Killer (NK) cell Killing, have been designed for use after hematopoietic stem cell transplantation (HSCT), where the proper stimulation of graft-derived NK cells has been shown to prevent relapse.

ThINKK immunotherapy builds on our earlier research on NK cells and plasmacytoid dendritic cells (PDC) in cord blood and after HSCT. PDC are the sentinels of the immune system. Upon viral nucleic acids detection, PDC secrete a vast array of chemokines and cytokines that stimulate NK cells. PDC stimulation enhances NK cells killing of infected cells that express stress-induced molecules. Cancer cells also express stress-related molecules at their surface. However, NK cells do not receive PDC stimulation when fighting cancer. ThINKK therapy is designed to provide this necessary stimulation.

Eligibility criteria

Qualifiers

Between 2 and less than 13 years old at time of informed consent form signature.

Diagnosis of acute leukemia or neuroblastoma.

Allogenic hematopoietic stem cell transplantation 30 to 90 days prior to eligibility confirmation.

Blood NK cell counts ≥ 100 x 10E+6 cells/L at least once before eligibility confirmation.

Disqualifiers

Current grade 3 or 4 acute GvHD (per MAGIC criteria).

Relapse of primary malignancy, or any other active malignancy.

For leukemia, defined as either morphological relapse or Minimal Residual Disease (MRD) ≥0.01% as measured by flow cytometry. MRD detected by polymerase chain reaction (PCR) does not constitute an exclusion criterion.

For neuroblastoma, defined as a progressive disease.

Trial design

Treatments tested in this trial

  • Therapeutic Inducers of Natural Killer Killing (ThINKK)

Treatment groups

12 Participants
are divided into 1 treatment group

Sponsors and collaborators

Michel Duval

Lead sponsor

St. Justine's Hospital

Sponsor institution

Héma-Québec

Collaborator

ExCellThera inc.

Collaborator

Centre C3i

Collaborator

Source ClinicalTrials.gov