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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

November 14, 2022

Primary Completion Date

December 1, 2026

Study Completion Date

December 1, 2027

Conditions
Pediatric Sarcoma, RefractoryPediatric Sarcoma, Relapsed
Interventions
BIOLOGICAL

GEM/DOX + TGFBi expanded NK cells

"8 cycles consisting of gemcitabine, docetaxel, supportive dexamethasone and pegfilagrastim, and universal donor, TGFBi ex vivo expanded NK cells~* Each cycle will be repeated every 21 days based upon disease response and toxicity criteria~* Tumor response assessed after Cycles 2, 4, 6, and 8~ 1. Gemcitabine 675mg/m2/dose IV on Days 1 and 8~ 2. Docetaxel 75mg/m2/dose IV on Day 8~ 3. Dexamethasone 3mg/m2/dose (max 8 mg/dose) PO BID on Days 7, 8, and 9~ 4. Pegfilgrastim (Peg-GCSF) 0.1mg/kg/dose (max 6 mg/dose) SQ on Day 9~ 5. NK cells 1 x 10e8 cells/kg/dose IV on Day 12 (+ 1-2 days)"

Trial Locations (16)

10467

RECRUITING

Montefiore Medical Center, The Bronx

14263

RECRUITING

Roswell Park Comprehensive Cancer Center, Buffalo

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

27710

RECRUITING

Duke Children's Hospital/Duke Health, Durham

28203

RECRUITING

Levine Cancer Institute, Charlotte

32207

RECRUITING

Nemours Jacksonville, Jacksonville

32610

RECRUITING

University of Florida, Gainesville

33136

RECRUITING

University of Miami, Miami

33701

RECRUITING

Johns Hopkins All Children's Hospital, St. Petersburg

35233

RECRUITING

University of Alabama, Birmingham

43205

RECRUITING

Nationwide Children's Hospital, Columbus

63110

RECRUITING

Washington University/St Louis Childrens, St Louis

75390

RECRUITING

UT Southwestern, Dallas

77030

RECRUITING

University of Texas MD Anderson Cancer Center, Houston

84113

RECRUITING

Primary Children's Hospital, Salt Lake City

90027

RECRUITING

Children's Hospital of Los Angeles, Los Angeles

All Listed Sponsors
collaborator

National Pediatric Cancer Foundation

OTHER

lead

Nationwide Children's Hospital

OTHER