NCT06450041

NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial

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: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: New Approaches to Neuroblastoma Therapy Consortium · Academic / Other
• Sex: All
• Age: 1 Year – 31 Years
• Healthy volunteers: Not accepted

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 body's defense (immune) system to kill neuroblastoma cells. NK cells are only present in the body in small numbers and often the patient's own NK cells don't 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 patient's 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.

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
DRUG	Universal Donor (UD) TGFβi NK Cells	Patients will receive a dose of 1x108 UD TGFβi NK cells/kg per treatment cycle on day 8 of each cycle
DRUG	Temozolomide	Enteral or IV daily on days 1-5 of each cycle For patients ≥ 0.5 m2: 100 mg/m2/dose For patients \< 0.5 m2: 3.3 mg/kg/dose MAXIMUM dose = 200 mg
DRUG	Irinotecan	50mg/m2/dose IV daily on days 1-5 of each cycle
DRUG	Dinutuximab	17.5mg/m2/dose IV daily on days 2-5 of each cycle
DRUG	GM-CSF	250mcg/m2/dose subcutaneous (preferred) or IV daily on days 6-12 of each cycle

Timeline

• Start date: 2024-12-16
• Primary completion: 2028-12-01
• Completion: 2038-12-01
• First posted: 2024-06-10
• Last updated: 2026-03-23

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study