This trial will study if adding NK cells to chemo can improve outcomes in kids w/ sarcomas that haven't responded to prior treatments.
- Pediatric Relapsed Sarcoma
- Refractory Pediatric Sarcoma
Phase 1 & 2
2 Primary · 2 Secondary · Reporting Duration: 3-5 years
Frequency and characterization of DLT in study patients
Treatment response of target lesions determined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
1 Treatment Group
1 of 1
50 Total Participants · 1 Treatment Group
Primary Treatment: Treatment · No Placebo Group · Phase 1 & 2
BiologicalExperimental Group · 1 Intervention: GEM/DOX + TGFBi expanded NK cells · Intervention Types: Biological
Screening: ~3 weeks
Reporting: 3-5 years
Who is running the clinical trial?
National Pediatric Cancer FoundationOTHER
4 Previous Clinical Trials
160 Total Patients Enrolled
2 Trials studying Sarcoma
122 Patients Enrolled for Sarcoma
Nationwide Children's HospitalLead Sponsor
319 Previous Clinical Trials
5,217,546 Total Patients Enrolled
1 Trials studying Sarcoma
86 Patients Enrolled for Sarcoma
Bhuvana Setty, MDPrincipal InvestigatorNationwide Children's Hospital
Age 12 - 40 · All Participants · 3 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
It's unclear what this criterion is referring to. Can you please provide more information?
You are taking chemotherapy medications that are not part of the study.
You can join the study if you have a history of seizures, but only if you are taking anti-seizure medication and have your seizures under control. However, you cannot participate if you are taking diazepam because it can affect the activity of certain immune cells.
- 2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05634369.