NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Nationwide Children's Hospital
Study ID
NCT04211675
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 29 Years
Healthy Volunteers
Not accepted

Interventions

  • Natural Killer Cells — BIOLOGICAL
    NK cells dose 1x 108 cells/ kg on day 8 of each cycle
  • Temozolomide — DRUG
    Temozolomide 100mg/m2/dose PO or IV daily on Days 1-5; if given orally, must be at least one hour prior to Irinotecan. For patients whose body surface area is \<0.5m2, temozolomide dosing is based on body weight in (kg), at a dose of 3.3 mg/kg/dose.
  • Irinotecan — DRUG
    Irinotecan 50mg/m2/dose IV daily on Days 1-5
  • Dinutuximab — DRUG
    Dinutuximab 17.5mg/m2/dose IV daily on Days 2-5
  • Sargramostim — DRUG
    Sargramostim 250mcg/m2/dose subcutaneous daily on Days 6-12

Study Details

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.

Key Dates

Start date
Sep 1, 2022
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
31 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Treatment
    The planned therapy will involve 6 cycles of 21 days each consisting of irinotecan, temozolomide, dinutuximab, sargramostim, and natural killer (NK) cells. Treatment cycles will be repeated every 21 days based upon disease response and toxicity criteria. Tumor response will be assessed after Cycles 2, 4 and 6. Patients who do not experience dose-limiting toxicities and achieve complete response, partial response or stable disease may continue to receive the assigned therapy.

Primary Outcome Measure

NK cells safety and tolerability: Number of participants with treatment-related adverse events and toxicities [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205
Mark Ranalli, MD
[email protected]
6142566590

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By specialty
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By research site
Nationwide Children's Hospital· Columbus, OH

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