Dirençli veya Metastatik GD2-pozitif Sarkom ve Nöroblastomda iC9-GD2-CAR-VZV-CTL Hücreleri

Sade dilde özet

Bu çalışma, tedaviye dirençli veya metastatik, GD2-pozitif sarkom (sarcoma) ve nöroblastom (neuroblastoma) hastalarında, genetik olarak düzenlenmiş GD2 hedefli T hücrelerini (GD2 CAR T hücreleri) VZV aşısı, Fludarabine ve Cyclophosphamide ile birlikte incelemektedir. Araştırmaya, standart tedaviye yanıt vermeyen, tekrarlayan veya dirençli osteosarkom ya da yüksek riskli nöroblastom tanılı hastalar dahil edilmektedir. Çalışma Faz 1 aşamasında yürütülmekte; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).

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

Deney bilgileri

Faz

Faz 1 (Phase 1)

Durum

Devam ediyor, katılım kapalı

Sponsor

Baylor College of Medicine

Müdahale

GD2 T cells, VZV vaccine, Fludarabine, Cyclophosphamide

Başlangıç

01.04.2014

Tahmini bitiş

31.10.2034

Ülkeler

United States

İlgili genler

Merkezler

• Houston, United States
• Houston, United States

Uygunluk kriterleri

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

Inclusion Criteria:

Procurement:

* Diagnosis of relapsed or refractory osteosarcoma OR relapsed or refractory high risk neuroblastoma not responsive to standard treatment.
* Either previously infected with varicella zoster virus(VZV; chicken pox) or previously vaccinated with VZV vaccine
* Karnofsky/Lansky score of greater than or equal to 50
* Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent

Treatment:

* Diagnosis of relapsed or refractory osteosarcoma OR relapsed or refractory high risk neuroblastoma not responsive to standard treatment.
* Recovered from the acute toxic effects of all prior chemotherapy
* Karnofsky/Lansky score of greater than or equal to 50
* Bilirubin less than or equal to 3x upper limit of normal, AST less than or equal to 5x upper limit of normal, Serum creatinine less than or equal to 2x upper limit of normal, Hgb greater than or equal to 7.0 g/dl, ANC\>500/uL, platelets \> 50,000/uL
* Pulse oximetry of greater than or equal to 90% on room air
* Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. Male partner should use a condom.
* Available autologous transduced cytotoxic T lymphocytes with greater than or equal to 20% expression of GD2 CAR and killing of GD2-positive targets greater than or equal to 20% in cytotoxicity assay
* Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent

Exclusion Criteria:

Procurement:

• Known primary immune deficiency or HIV positivity

Treatment:

* Severe intercurrent infection
* Known primary immune deficiency or HIV positivity
* Pregnant or lactating
* History of hypersensitivity reactions to murine protein-containing products
* Known allergy to VZV vaccine