NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeUp to 29
SponsorNationwide Children's Hospital
About this trial
This is a Phase 1 study with Phase 2 expansion cohort. Phase 1 will assess the safety and tolerability of universal donor TGFβi NK Cell in combination with irinotecan, temozolomide, and dinituximab. The phase 2 of the study will estimate the response to treatment.
Eligibility criteria
Qualifiers
Less than 30 years of age when registered on the study.
Patients must have a histologic verification of neuroblastoma (NBL) or ganglioneuroblastoma or NBL cells in bone marrow with or without elevated urine catecholamines.
Recurrent disease; or
First episode of progressive disease (new lesion, increase in size, previous negative bone marrow) during initial multi-drug, induction myelosuppressive therapy; or
Disqualifiers
Patients who are pregnant or breastfeeding
Patients with elevated catecholamines (>2x ULN) only.
Patients must not have received 0.5 mg/ kg/ day (prednisone equivalent) doses of systemic steroids for at least 7 days prior to enrollment.
Patients must not have received CYP3A4 inducer or inhibitor for at least 7 days prior to study enrollment.
Trial design
Treatments tested in this trial
- Natural Killer Cells
- Temozolomide
- Irinotecan
- Dinutuximab
- Sargramostim
Treatment groups
31 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov