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

{ "Phase 1 Study of Locoregional Injections of Ex Vivo Expanded Natural Killer Cells for High Grade Glioma", "This study is testing a new treatment called TGFβi NK cells for people aged 12 months to 39 years with high-grade glioma (a type of brain tumor) that has come back, gotten worse, or hasn't responded to other treatments. The TGFβi NK cells are given directly into the brain cavity through a special port (Ommaya intra-cavitary/a programable ventriculoperitoneal (VP) shunt). The main goal is to find the safest and most effective dose of these cells. Participants will receive up to 12 cycles of treatment, with each cycle lasting 4 weeks. During the first 3 weeks of each cycle, you would receive weekly infusions of the cells, followed by a rest week. This study aims to enroll 18 participants.", "design": "This is a Phase 1 interventional study, meaning it's an early-stage trial focused on safety and dosage. It plans to enroll 18 participants.", "commitments": "You would receive weekly infusions of TGFβi NK cells for three weeks, followed by a one-week rest, for up to 12 cycles. Each cycle lasts 28 days.", "compensation": "Not stated in the trial record.", "follow_up": "The primary endpoints (main goals) for safety and dose are measured at 36 months, suggesting a follow-up period of at least three years.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

PHASE1Ages 12–39InterventionalTreatment

Nationwide Children's Hospital

~18 participants

Updated 2025-05-13 on ClinicalTrials.gov

What's tested:NK cells

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Maximum tolerated dose or Recommended Phase 2 Dose (RP2D)

Measured over 36 months

+1 more outcome measured

Conditions

High Grade Glioma

Where it's being run

1 sites across 1 states

Ohio1

Study leadership

Sara Khan, MD · PRINCIPAL_INVESTIGATOR · Nationwide Children's Hospital

Who to contact

Clelie Peck

[email protected]

614-722-5634

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients with a histologically confirmed diagnosis of a CNS tumor that is recurrent, progressive, or refractory with the exception of diffuse midline gliomas (DMG) or Diffuse Intrinsic Pontine Gliomas (DIPG). All tumors must have histologic verification at either the time of diagnosis or recurrence.

Patients should be deemed candidate for placement of an Ommaya reservoir placed intra-cavitary/intra-tumoral or a programable VP shunt.

Measurable residual tumor after surgery is not required for study entry.

Resection cavity needs to be at least 2 cm x 2 cm in two dimensions on imaging for patients deemed as candidates for an intratumoral infusion via an Ommaya reservoir.

Performance score: Lansky score of 50 or greater if ≤ 16 years of age or a Karnofsky score of 50 or greater if \> 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.

Adequate bone marrow function, without transfusion or growth factors within 21 days of NK cell administration.

Adequate liver function

Adequate Renal Function

Prothrombin time/international normalized ratio

Patients of child-bearing potential must agree to use adequate contraception

Adequate neurologic function defined

Chemotherapy

All patients must have received their last dose of known myelosuppressive anticancer therapy at least 21 days prior to enrollment or at least 42 days of nitrosourea.

For patients who have received prior bevacizumab, at least 6 weeks must have elapsed prior to enrollment.

Biologic or investigational agent (anti-neoplastic, non-myelosuppressive):

Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent ≥ 14 days prior to study enrollment.

For agents with known adverse events occurring beyond 14 days after administration, this period must be extended beyond the time during which adverse events are known to occur.

At least 12 weeks since the completion of any immunotherapies or cell therapies.

Radiation Therapy

Focal radiation therapy \> 6 weeks prior to enrollment.

Craniospinal irradiation \>12 weeks.

Stem Cell Transplant.

≥ 6 months since allogeneic stem cell transplant prior to enrollment with no evidence of active graft vs. host disease.

≥ 3 months since autologous stem cell transplant prior to enrollment.

Patients must be off all colony- forming growth factor(s) for at least 1 week prior to enrollment (e.g., filgrastim, sargramostim or erythropoietin).

2 weeks must have elapsed if patients received long-acting formulations.

Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to enrollment.

Exclusion

Patients with intra- or extra-CNS metastasis or multi-focal disease.

Patients with diffuse midline gliomas or Diffuse Intrinsic Pontine Gliomas (primary or recurrent).

Pregnant or lactating patients.

Participants who are receiving any other investigational agents.

Evidence of active uncontrolled infection or unstable or severe intercurrent medical conditions.

Any medical condition that precludes surgery.

Patients with a known disorder that affects their immune system, such as human immunodeficiency virus (HIV), or an auto- immune disorder requiring systemic cytotoxic or immunosuppressive therapy are not eligible.

Evidence of bleeding diathesis or use of anticoagulant medication or any medication which may increase the risk of bleeding.

Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible.

History or current diagnosis of any medical or psychological condition that in the Investigator's opinion, might interfere with the subject's ability to participate

What this trial measures

Maximum tolerated dose or Recommended Phase 2 Dose (RP2D)36 months
To determine the maximum tolerated dose (MTD) and/or the RP2D of UD TGFβi NK cells that have been propagated ex vivo with genetically modified feeder cells and administered using an Ommaya reservoir (into tumor cavity) or a programable ventriculoperitoneal shunt (intraventricular).
Maximum tolerated dose36 months
To establish the maximum tolerated dose (MTD) of autologous natural killer cells that have been propagated ex vivo with genetically-modified feeder cells and administered intra-tumoral via Ommaya reservoir in patients with recurrent high-grade glioma. MTD will be the maximum dose at which fewer than one-third of patients experience a dose-limiting toxicity during cycle 1 of therapy

Trialytics