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Report for Clinical Trial NCT04254419

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase I Study of Intra-Tumoral Injections of Autologous Ex Vivo Expanded Natural Killer Cells in Children With Recurrent High Grade Glioma

Patients will receive 3 cycles of NK cell infusions over 12 weeks. Each cycle will consist of 1 infusion per week for 3 weeks, followed by a rest week (week 4). Dose will be escalated in an inter-patient stepwise fashion consisting of 4 dose levels.

NCT04254419 High Grade Glioma
MeSH:Glioma
HPO:Glioma

1 Interventions

Name: NK cells

Description: Natural killer cells will be taken from the patients peripheral blood cell collection. The administration of the cells will be done via an Ommaya intra-cavitary/intra-tumoral device. 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 in approximately 2 milliliters over approximately 2 minutes; followed by 1 milliliter preservative-free normal saline flush over approximately 1 minute.
Type: Biological
Group Labels: 1

NK cell infusion


Primary Outcomes

Description: To identify the incidence of adverse events from 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. This will be evaluated using the CTCAE version 5

Measure: Incidence of adverse events from NK cells

Time: 36 months

Description: 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

Measure: Maximum tolerated dose

Time: 36 months

Secondary Outcomes

Description: To determine the overall survival, defined as the percentage of patients in the study who are alive at 6 months following start of treatment

Measure: Overall survival

Time: 6 months

Other Outcomes

Description: To assess the antitumor activity based on imaging and cytology of autologous NK cell administration directly into the tumor or the resection cavity.

Measure: NK cell antitumor activity

Time: 36 months

Description: NK cell phenotypes will be measured by mass cytometry (unit of measure= % of nucleated cells)

Measure: Assessment of the immuno-phenotype of expanded NK cells for high-grade glioma patients

Time: 36 months

Description: NK cell functional potency will be measured as cytotoxicity by calcien- AM cytotoxicity assays (unit of measure= % of patietns with complete response (CR), very good partial response (VGPR), partial response (PR), stable disease (SD), or progressive disease (PD) with calculated 95% confidence intervals)

Measure: Assessment of function of expanded NK cells for high-grade glioma patients

Time: 36 months

Description: To determine the immune signature-based profile of each patient's tumor as assayed by the NanoString PanCancer IO360 panel

Measure: Assessment of the immune signature based profile

Time: 36 months

Description: To determine the o6-methylguanine-DNA-methyltransferase (MGMT) methylation and mutation status of BRAF V600E, ACVR1, ATRX, TP53, H3.3 G34, H3.3/ H3.1 K27 and IDH1, along with the presence or absence of 9p21 (CDKN2A) homozygous deletion as well as PDGFR amplification

Measure: Determination of genetic changes on high-grade gliomas

Time: 36 months

Description: To determine changes in the TCR repertoire diversity using a Nanostring custom reagent that evaluates the VDJ sequences present before and after NK cell treatment.

Measure: Changes of the T-cell Receptor Repertoires

Time: 36 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V600E

To determine the o6-methylguanine-DNA-methyltransferase (MGMT) methylation and mutation status of BRAF V600E, ACVR1, ATRX, TP53, H3.3 G34, H3.3/ H3.1 K27 and IDH1, along with the presence or absence of 9p21 (CDKN2A) homozygous deletion as well as PDGFR amplification. --- V600E ---



HPO Nodes


HPO: