Ignite Creation Date:
2024-05-06 @ 6:21 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05634369
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2022-11-15
Brief Title:
A Multi-Institution Study of TGFβ Imprinted Ex Vivo Expanded Universal Donor NK Cell Infusions As Adoptive Immunotherapy in Combination with Gemcitabine and Docetaxel in Patients with Relapsed or Refractory Pediatric Bone and Soft Tissue
Sponsor:
Nationwide Childrens Hospital
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
A Multi-Institution Study of TGFβ Imprinted Ex Vivo Expanded Universal Donor NK Cell Infusions As Adoptive Immunotherapy in Combination with Gemcitabine and Docetaxel in Patients with Relapsed or Refractory Pediatric Bone and Soft Tissue
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TINKS
Brief Summary:
The purpose of this study is to determine if the addition of infusions of a type of immune cell called a natural killer or NK cell to the sarcoma chemotherapy regimen GEMDOX gemcitabine and docetaxel can improve outcomes in people with childhood sarcomas that have relapsed or not responded to prior therapies
The goals of this study are
To determine the safety and efficacy of the addition of adoptive transfer of universal donor TGFβ imprinted TGFβi expanded NK cells to the pediatric sarcoma salvage chemotherapeutic regimen gemcitabinedocetaxel GEMDOX for treatment of relapsed and refractory pediatric sarcomas To determine the 6-month progression free survival achieved with this treatment in patients within cohorts of relapsed or refractory osteosarcoma Ewing sarcoma rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma
To identify toxicities related to treatment with GEMDOX TGFβi expanded NK cells
Participants will receive study drugs that include chemotherapy and NK cells in cycles each cycle is 21 days long and you can receive up to 8 cycles
Gemcitabine GEM via IV on Days 1 and 8
Docetaxel DOX via IV on Day 8
Prophylactic dexamethasone Day 7-9 to prevent fluid retention and hypersensitivity reaction
Peg-filgrastim PEG-GCSF or biosimilar Day 9 to help your white blood cell recover and allow more chemotherapy to be given
TGFβi NK cells via IV on Day 12
The goals of this study are
To determine the safety and efficacy of the addition of adoptive transfer of universal donor TGFβ imprinted TGFβi expanded NK cells to the pediatric sarcoma salvage chemotherapeutic regimen gemcitabinedocetaxel GEMDOX for treatment of relapsed and refractory pediatric sarcomas To determine the 6-month progression free survival achieved with this treatment in patients within cohorts of relapsed or refractory osteosarcoma Ewing sarcoma rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma
To identify toxicities related to treatment with GEMDOX TGFβi expanded NK cells
Participants will receive study drugs that include chemotherapy and NK cells in cycles each cycle is 21 days long and you can receive up to 8 cycles
Gemcitabine GEM via IV on Days 1 and 8
Docetaxel DOX via IV on Day 8
Prophylactic dexamethasone Day 7-9 to prevent fluid retention and hypersensitivity reaction
Peg-filgrastim PEG-GCSF or biosimilar Day 9 to help your white blood cell recover and allow more chemotherapy to be given
TGFβi NK cells via IV on Day 12
Detailed Description:
This is a multi-center study with rolling safety and toxicity analysis to determine the safety and efficacy of the addition of adoptive transfer of universal donor TGFβ imprinted TGFβi expanded NK cells to the pediatric sarcoma salvage chemotherapeutic regimen gemcitabinedocetaxel GEMDOX for treatment of relapsed and refractory pediatric sarcomas identify toxicities related to treatment with GEMDOX TGFβi expanded NK cells and assess in vivo persistence of expanded universal donor TGFβi NK cells after adoptive transfer and correlate with clinical outcomes
The planned therapy will involve 8 cycles of 21 days each consisting of gemcitabine docetaxel supportive dexamethasone and peg-filgrastim and universal donor TGFβi ex vivo expanded NK cells Cycles 1-6
The planned therapy will involve 8 cycles of 21 days each consisting of gemcitabine docetaxel supportive dexamethasone and peg-filgrastim and universal donor TGFβi ex vivo expanded NK cells Cycles 1-6
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