Actively Recruiting
Phase 1 Study of Locoregional Injections of Ex Vivo Expanded Natural Killer Cells
Led by Nationwide Children's Hospital · Updated on 2025-05-13
18
Participants Needed
1
Research Sites
343 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1 Study of Locoregional Injections of Ex Vivo Expanded Natural Killer Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of recurrent, refractory, or progressive malignant CNS tumor excluding diffuse midline gliomas or diffuse intrinsic pontine gliomas
- Histologic verification of tumor at diagnosis or recurrence
- Candidate for placement of an Ommaya reservoir or programmable VP shunt
- Resection cavity at least 2 cm x 2 cm for intratumoral infusion
- Lansky score of 50 or greater if 16 years or younger, Karnofsky score of 50 or greater if older than 16
- Adequate bone marrow, liver, renal function, and prothrombin time/international normalized ratio
- Use of adequate contraception if of child-bearing potential
- Stable or decreasing corticosteroid dose for at least 1 week prior to enrollment
- Last dose of myelosuppressive chemotherapy at least 21 days prior (42 days if nitrosourea)
- Last dose of bevacizumab at least 6 weeks prior
- Recovery from acute toxicity of investigational or biologic agents and last dose at least 14 days prior
- At least 12 weeks since completion of immunotherapy or cell therapy
- Focal radiation therapy more than 6 weeks prior, craniospinal irradiation more than 12 weeks prior
- At least 6 months since allogeneic stem cell transplant with no active graft vs. host disease
- At least 3 months since autologous stem cell transplant
- Off colony-forming growth factors for at least 1 week (2 weeks for long-acting)
You will not qualify if you...
- Presence of intra- or extra-CNS metastasis or multifocal disease
- Diagnosis of diffuse midline gliomas or diffuse intrinsic pontine gliomas
- Pregnant or lactating
- Receiving other investigational agents
- Active uncontrolled infection or severe intercurrent medical conditions
- Any medical condition preventing surgery
- Known immune system disorders such as HIV or autoimmune disorders needing systemic immunosuppressive therapy
- Evidence of bleeding disorders or use of anticoagulants or medications increasing bleeding risk
- Inability to comply with safety monitoring
- Medical or psychological conditions interfering with participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
Research Team
C
Clelie Peck
CONTACT
L
Lauren Rayman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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