Nükseden veya Dirençli Osteosarkom ve Nöroblastomda NKG2D.Zeta-NK Hücre Hazırlığı ile C7R.GD2.CAR-T Hücreleri

Sade dilde özet

Bu çalışma, standart tedaviye rağmen hastalığı süren ya da nükseden osteosarkom veya nöroblastom hastalarında, genetik olarak donatılmış NK hücreleri ile GD2 hedefli CAR-T hücrelerinin ardışık kullanımını incelemektedir. Faz 1 aşamasında yürütülmekte ve katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 1 (Phase 1)

Durum

Katılımcı alıyor

Sponsor

Baylor College of Medicine

Müdahale

i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells, i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells, i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells

Başlangıç

15.07.2026

Tahmini bitiş

01.04.2044

Ülkeler

United States

İlgili genler

Merkezler

• Houston, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

PROCUREMENT INCLUSION:

1. Patients with Neuroblastoma that have persistent disease after standard treatment or have relapsed/refractory disease.

   Or

   Patients with Osteosarcoma that have persistent disease after standard treatment or have relapsed/refractory disease.
2. Karnofsky/Lansky score of 60% or greater.
3. Informed consent and assent (as applicable) obtained from parent/guardian and child.
4. Greater than 1 year of age.

PROCUREMENT EXCLUSION:

1. History of hypersensitivity to murine protein-containing products.
2. Known presence of Human Anti-Mouse Antibodies (HAMA).
3. Active autoimmune disease (requiring immunosuppressive treatment in the past 6 months).
4. Primary brain tumor or known brain metastases (on evaluation by MIBG and/or PET if applicable, CT/MRI/LP not required).

TREATMENT INCLUSION:

1. Patients with Neuroblastoma that have persistent disease after standard treatment or have relapsed/refractory disease.

   Or

   Patients with Osteosarcoma that have persistent disease after standard treatment or have relapsed/refractory disease.
2. Karnofsky/Lansky score of 50% or greater
3. Pulse Ox greater than or equal to 90% on room air
4. AST less than 5 times upper limit of normal (less than 10 times upper normal if known with metastatic liver disease)
5. Total bilirubin less than 3 times the upper limit of normal
6. Serum creatinine less than 3 times upper limit of normal
7. Available autologous T-cells with greater than or equal to 20% expressing GD2.CAR
8. Informed consent and assent (as applicable) obtained from parent/guardian and child.
9. Greater than 1 year of age.
10. Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study.

TREATMENT EXCLUSION:

1. History of hypersensitivity to murine protein containing products (patients who have undergone desensitization and successful re-challenge without hypersensitivity reaction are eligible).
2. Known presence of Human Anti-Mouse Antibodies (HAMA).
3. Tumor potentially causing airway obstruction per investigator discretion.
4. Pregnancy or lactation / will not use birth control methods.
5. Currently receiving immunosuppressive drugs (patients on low dose corticosteroids are eligible: less than 0.25 mg/kg/day of prednisone/equivalent).
6. Primary brain tumor or known brain metastases (on evaluation by MIBG and/or PET if applicable, CT/MRI/LP not required).