Phase I Clinical Trial of ThINKK Adoptive Immunotherapy After Allogeneic Hematopoietic Transplant… (NCT07518654) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Phase I Clinical Trial of ThINKK Adoptive Immunotherapy After Allogeneic Hematopoietic Transplantation in Children With Leukemia or Neuroblastoma
Canada12 participantsStarted 2026-05-01
Plain-language summary
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.
Who can participate
Age range2 Years – 12 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Life expectancy of ≥ 3 months per investigator's judgment at time of eligibility confirmation.
✓. Patient or legally acceptable representative has provided informed consent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
Exclusion criteria
✕. 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.
What they're measuring
1
Incidence and severity of treatment-emergent adverse events and serious adverse events
Timeframe: From first study drug administration to 4 weeks after last administration
2
Incidence of dose-limiting toxicities
Timeframe: From first study drug administration to 4 weeks after last administration
3
Incidence and severity of treatment-related adverse events
Timeframe: From first study drug administration to 4 weeks after last administration
✕. For neuroblastoma, defined as a progressive disease.
✕. Ongoing therapy with systemic corticosteroids (equivalent to a prednisone dose \>0.5 mg/kg/day). Patients actively undergoing corticosteroid tapering during Screening may be enrolled once they have reached a prednisone-equivalent dose ≤ 0.5 mg/kg/day with Sponsor-Investigator approval, with the expectation that the taper will continue.
✕. Ongoing systemic therapy with cyclosporine.
✕. Administration or planned administration of any prohibited treatment listed in ad hoc section.
✕. Aspartate aminotransferase and alanine aminotransferase serum levels ≥5 times the upper limit of normal.