Phase 1 Study of Locoregional Injections of Ex Vivo Expanded Natural Killer Cells

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Nationwide Children's Hospital
Study ID
NCT04254419
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • High Grade Glioma

Eligibility Criteria

Sex
ALL
Age
12 Months - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • NK cells — BIOLOGICAL
    The universal donor TGFβi NK cells will be cryopreserved until they are delivered bedside for infusion. The trained staff will thaw the product by the bedside. The administration of the cells will be done via an Ommaya intra-cavitary/a programable ventriculoperitoneal (VP) shunt. Once the infusion is ready for administration patients will be admitted to the infusion unit for monitoring. NK cells will be administered through the Ommaya/VP shunt in approximately 3 milliliters over approximately 2-5 minutes; followed by 1.5-2 milliliter preservative-free normal saline flush over approximately 1 minute.

Study Details

Each patient will receive up to 12 cycles of TGFβi NK cell infusions. Each cycle will be of 4 weeks duration. During the first 3 weeks, TGFβi NK cells will be infused once weekly. The 4th week will be a rest week. TGFβi NK cell infusions should be delivered at least 3 days apart (e.g., Friday of Week 1 and Monday of Week 2). Dose will be escalated in an inter-patient stepwise fashion consisting of 3 dose levels.

Key Dates

Start date
Mar 4, 2025
Status verified
Mar 2025
Primary completion
Dec 31, 2030
Completion
Oct 31, 2031

Study Design

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

Arms

  • Experimental: NK cell infusion
    The TGFβi NK cell product on this trial will be manufactured in the Cell Based Therapy (CBT) Core facility at Nationwide Children's Hospital. Donors have been identified with specific universal-donor NK cell characteristics. The NK cells are collected from these donors via apheresis and then undergo CD3 depletion followed by a 2-week expansion. TGFβi NK cells are then generated by weekly stimulation with feeder cells and cultured in IL-2 and TGFβ. After 2 weeks, the TGFβi NK cells are washed and cryopreserved for future use. The expanded donor NK cell product will be manufactured prior to subject enrollment. Patients will receive 3 cycles of NK cell infusions over 12 weeks. Each cycle will consist of three weekly injections followed by a rest week (week 4). If patients have stable or improved disease and additional doses are available, patients may continue to receive therapy for a total of 12 cycles.

Primary Outcome Measure

Maximum tolerated dose or Recommended Phase 2 Dose (RP2D) [ Time Frame: 36 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205
Clelie Peck
[email protected]
614-722-5634
Sara Khan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbus, OH

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

Related Studies