Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450041
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-31
Brief Title:
NANT 2021-01 Phase II STING Sequential Temozolomide Irinotecan NK Cells and GD2 mAb Trial
Sponsor:
New Approaches to Neuroblastoma Therapy Consortium
Organization:
New Approaches to Neuroblastoma Therapy Consortium
Study Overview
Official Title:
Phase II Study of Ex-Vivo Expanded Allogeneic Universal Donor TGFβi NK Cell Infusions in Combination With Temozolomide Irinotecan Dinutuximab and Sargramostim in Patients With Relapsed or Refractory Neuroblastoma The STING Sequential Temozolomide Irinotecan NK Cells and GD2 mAb Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
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:
None
Brief Summary:
This is a phase II study looking at patient response to treatment with the combination dinutuximab temozolomide irinotecan and GM-CSF
Detailed Description:
Currently there are very few effective treatments for high-risk neuroblastoma that has returned or that has not responded to treatment
One treatment that works relatively well for this type of neuroblastoma is a combination of four medicines dinutuximab temozolomide irinotecan and GM-CSF Dinutuximab is an antibody that attacks neuroblastoma cells Temozolomide and irinotecan are two chemotherapy medicines GM-CSF helps to boost the immune system This study is trying to learn if this treatment which is called chemoimmunotherapy can work better by adding NK cells
The immune system is made up of different cell types One type of immune cell is the natural killer NK cell NK cells use the bodys defense immune system to kill neuroblastoma cells NK cells are only present in the body in small numbers and often the patients own NK cells dont work very well against their tumor because neuroblastoma releases chemicals that weaken the NK cells One of these chemicals is called TGF-beta
This study uses a newer process to make specially chosen donated NK cells which may work better than the patients own NK cells This new type of donated NK cells are called TGF-beta imprinted which may be better killers of tumors like neuroblastoma because they have already been exposed to TGF-beta while they are being prepared and grown The special NK cells for this study have already been collected from donors selected for this study and are stored for use Prior studies have used these types of NK cells or similar NK cells for other tumors or neuroblastoma
Once treatment begins patients will receive temozolomide and irinotecan for 5 consecutive days with the addition of dinutuximab daily on days 2-5 If patients tolerate this chemoimmunotherapy they will receive the donor TGF-beta NK cells on day 8 Patients can have this treatment for up to 6 cycles total
One treatment that works relatively well for this type of neuroblastoma is a combination of four medicines dinutuximab temozolomide irinotecan and GM-CSF Dinutuximab is an antibody that attacks neuroblastoma cells Temozolomide and irinotecan are two chemotherapy medicines GM-CSF helps to boost the immune system This study is trying to learn if this treatment which is called chemoimmunotherapy can work better by adding NK cells
The immune system is made up of different cell types One type of immune cell is the natural killer NK cell NK cells use the bodys defense immune system to kill neuroblastoma cells NK cells are only present in the body in small numbers and often the patients own NK cells dont work very well against their tumor because neuroblastoma releases chemicals that weaken the NK cells One of these chemicals is called TGF-beta
This study uses a newer process to make specially chosen donated NK cells which may work better than the patients own NK cells This new type of donated NK cells are called TGF-beta imprinted which may be better killers of tumors like neuroblastoma because they have already been exposed to TGF-beta while they are being prepared and grown The special NK cells for this study have already been collected from donors selected for this study and are stored for use Prior studies have used these types of NK cells or similar NK cells for other tumors or neuroblastoma
Once treatment begins patients will receive temozolomide and irinotecan for 5 consecutive days with the addition of dinutuximab daily on days 2-5 If patients tolerate this chemoimmunotherapy they will receive the donor TGF-beta NK cells on day 8 Patients can have this treatment for up to 6 cycles total
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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