Ignite Creation Date:
2024-05-06 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03242603
Status:
UNKNOWN
Last Update Posted:
2018-03-30
First Post:
2017-07-13
Brief Title:
Immunotherapy of Neuroblastoma Patients Using a Combination of Anti-GD2 and NK Cells
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
Pilot Study of Anti-GD2 and Expanded Activated Natural Killer Cell Infusion for Neuroblastoma
Status:
UNKNOWN
Status Verified Date:
2017-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NKEXPGD2
Brief Summary:
Neuroblastoma is a neoplasm of the sympathetic nervous system which affects mostly children younger than 5 years of age It is a heterogeneous disease with nearly 50 of patients presenting with a high-risk phenotype After standard treatment the 2-year event-free survival EFS for high risk neuroblastoma EFS is only about 50 Immunotherapy with anti-GD2 antibodies has been shown to improve EFS in Childrens Oncology Group and SIOPEN trials
The anti-GD2 antibody mediates neuroblastoma cell killing primarily through antibody-dependent cell-mediated cytotoxicity ADCC Natural killer NK cells are the main effectors of ADCC We postulate that infusion of expanded activated NK cells from healthy haploidentical donors along with anti-GD2 antibody will enhance neuroblastoma killing
The anti-GD2 antibody mediates neuroblastoma cell killing primarily through antibody-dependent cell-mediated cytotoxicity ADCC Natural killer NK cells are the main effectors of ADCC We postulate that infusion of expanded activated NK cells from healthy haploidentical donors along with anti-GD2 antibody will enhance neuroblastoma killing
Detailed Description:
Adoptive transfer of haploidentical NK cells has been shown to be safe in clinical trials at NUH There is experience combining antibody infusion with autologous NK cells in the clinical trial with good safety data
The proposed trial is a phase III study to determine the safety and efficacy of expanded activated haploidentical NK cells in combination with anti-GD2 ch1418CHO We plan to enrol patients with high risk or relapsed neuroblastoma with evidence of residual disease who are at high risk of recurrence or progression on current treatment
In the proposed protocol we plan to infuse NK cells at escalating dose levels to find the optimum dose tolerated by the patients in combination with anti-GD2 ch1418CHO There are 3 NK cell dose levels
Dose level 1 1 x 106kg Dose level 2 1 x 107kg Dose level 3 1 x 108kg
If a partial response or stable disease is observed further infusions of NK cells can be administered There will be intra- and inter - patient dose escalation
The donor will be either parent based on the best NK cell donor as determined by the study team The donor will be harvested and NK cells expanded prior to infusion into the patient along with anti-GD2 ch1418CHO
The study aims to study safety and efficacy of a combination of NK cells and anti-GD2 ch1418CHO
The proposed trial is a phase III study to determine the safety and efficacy of expanded activated haploidentical NK cells in combination with anti-GD2 ch1418CHO We plan to enrol patients with high risk or relapsed neuroblastoma with evidence of residual disease who are at high risk of recurrence or progression on current treatment
In the proposed protocol we plan to infuse NK cells at escalating dose levels to find the optimum dose tolerated by the patients in combination with anti-GD2 ch1418CHO There are 3 NK cell dose levels
Dose level 1 1 x 106kg Dose level 2 1 x 107kg Dose level 3 1 x 108kg
If a partial response or stable disease is observed further infusions of NK cells can be administered There will be intra- and inter - patient dose escalation
The donor will be either parent based on the best NK cell donor as determined by the study team The donor will be harvested and NK cells expanded prior to infusion into the patient along with anti-GD2 ch1418CHO
The study aims to study safety and efficacy of a combination of NK cells and anti-GD2 ch1418CHO
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None