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

Sponsor
Michel Duval
Study ID
NCT07518654
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Hematopoetic Stem Cell Transplant
  • Hematopoetic Stem Cell Transplantation
  • Leukaemia (Acute Lymphoblastic)
  • Leukaemia (Acute Myeloid)
  • Leukaemia, Lymphoblastic, Acute
  • Leukemia (Both ALL and AML)
  • Leukemia Acute Myeloid
  • Leukemia Acute Myeloid - AML
  • Neuroblastoma
  • Neuroblastoma, Metastatic

Eligibility Criteria

Sex
ALL
Age
2 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Therapeutic Inducers of Natural Killer Killing (ThINKK) — DRUG
    This study uses an adaptation of the classical 3+3 dose-escalation model. The Maximum Tolerated Dose (MTD) is determined as the highest dose level at which six patients are treated with no unacceptable increase in acute GvHD risk and with no more than one patient experiencing a DLT. The first cohort (3 patients) will receive 7.5 M ThINKK/m2 weekly for 4 weeks. Dose distribution for the escalation levels will be guided by the pharmacodynamic data from the initial cohort.. If the preliminary data show that TRAIL expression remains stable at Day +8, dose level 2 will be set at 15 × 10\^6 / m2 BSA weekly, and dose level 3 at 30 × 10\^6 / m2 BSA weekly. If the data instead indicate the need to shorten the dosing interval to maintain TRAIL expression, dose level 2 will be set at 7.5 × 10\^6 / m2 BSA bi-weekly and dose level 3 at 15 × 10\^6 / m2 BSA bi-weekly.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
May 1, 2029
Completion
May 1, 2029

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment

Primary Outcome Measure

Incidence and severity of treatment-emergent adverse events and serious adverse events [ Time Frame: From first study drug administration to 4 weeks after last administration ]

Central Contacts

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