NY-ESO-1 Pozitif İlerlemiş Miksoid/Yuvarlak Hücreli Liposarkomu Olan Katılımcılarda Genetik Olarak Düzenlenmiş Letetresgene Autoleucel T Hücreleri

Sade dilde özet

Bu çalışma, NY-ESO-1 pozitif, ilerlemiş miksoid/yuvarlak hücreli liposarkom (myxoid/round cell liposarcoma) olan hastalarda genetik olarak düzenlenmiş T hücreleriyle uygulanan Letetresgene autoleucel (GSK3377794) tedavisini incelemektedir. Tedavi öncesinde Cyclophosphamide ve Fludarabine ilaçları kullanılmıştır; çalışmaya HLA-A*02 pozitif, daha önce antrasiklin bazlı tedavi almış 18 yaş üstü hastalar alınmıştır. Çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

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

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

GlaxoSmithKline

Müdahale

letetresgene autoleucel (GSK3377794), Cyclophosphamide, Fludarabine

Başlangıç

06.12.2016

Tahmini bitiş

22.03.2022

Ülkeler

United States

İlgili genler

Merkezler

• Tampa, United States
• Ann Arbor, United States
• St Louis, United States
• New York, United States
• Columbus, United States
• Houston, United States

Uygunluk kriterleri

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

Inclusion Criteria:

* Participant is greater than equal to (\>=)18 years of age at the time of signing the study informed consent.
* Participant has a diagnosis of advanced (metastatic or inoperable) high grade myxoid liposarcoma / myxoid round cell liposarcoma confirmed histologically and by the presence of the reciprocal chromosomal translocation t(12;16) (q13;p11) or t(12; 22) (q13;q12).
* Participant has measurable disease according to RECIST v1.1 criteria.
* Participant must have previously received or be intolerant to anthracycline based therapy for advanced (metastatic or inoperable) disease.
* Participants who received neoadjuvant/adjuvant anthracycline based therapy and progressed within 6 months of completion of therapy will be eligible.
* Participant must be HLA A\*02:01, HLA A\*02:05 and/or HLA-A\*02:06 positive.
* Participant's tumor (either the most recent archival specimen or a fresh biopsy) is positive for NY-ESO-1 expression by a designated central laboratory.
* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
* Participant has a left ventricular ejection fraction \>=45%.
* Participant is fit for apheresis and has adequate venous access for the cell collection.
* Participants must satisfy pregnancy and contraceptive requirements per protocol and have adequate organ function per protocol specified values.

Exclusion Criteria:

* Any previous gene therapy using an integrating vector.
* Any previous allogeneic hematopoietic stem cell transplant.
* Participant has history of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study.
* Participant has history of chronic or recurrent (within the last year prior to screening) severe autoimmune or immune mediated disease requiring steroids or other immunosuppressive treatments.
* Participant has known active brain or leptomeningeal metastases.
* Participant has other prior malignancy that is not in complete remission.
* Participant has uncontrolled intercurrent illness including, but not limited to:
* (i) Ongoing or active infection.
* (ii) Clinically significant cardiac disease
* (iii) Interstitial lung disease (participants with existing pneumonitis as a result of radiation are not excluded, however, participants must not be oxygen dependent).
* Participant has active infection with Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV), ), Hepatitis C virus (HCV) or human T-lymphotropic virus (HTLV).