Nüks Etmiş veya Dirençli CD30 Pozitif Lenfoma Hastalarında Allojenik CD30.CAR-EBVST'ler

Sade dilde özet

Bu Faz 1 (Phase 1) çalışma, sağlıklı vericilerden elde edilip bankada dondurularak saklanan, Epstein-Barr virüsüne (EBV) özgü ve CD30'a yönelik kimerik antijen reseptörü (chimeric antigen receptor, CAR) taşıyan allojenik (allogeneic) T hücrelerini (CD30.CAR-EBVST) inceliyor. Çalışma, nüks etmiş veya tedaviye dirençli CD30 pozitif lenfoması (diffüz büyük B hücreli lenfoma, NK/T hücreli lenfoma veya klasik Hodgkin lenfoma; relapsed or refractory CD30-positive lymphoma) olan ve standart tedavisi bulunmayan ya da mevcut tedavilerin yeterli olmadığı hastaları kapsıyor. Katılımcıların 12–75 yaş arasında olması ve tümörün sertifikalı bir laboratuvarda CD30 pozitif bulunmuş olması gerekmektedir.

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

CD30.CAR-EBVST cells (Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes)

Başlangıç

16.09.2020

Tahmini bitiş

01.06.2037

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:

1. Diagnosis and clinical course falling into one of the following categories:

   1. Hodgkin lymphoma
   2. Aggressive non-Hodgkin lymphoma
   3. ALK-negative anaplastic T cell lymphoma or other peripheral T-cell lymphoma
   4. ALK-positive anaplastic T cell lymphoma
2. CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory.
3. Age 12 to 75.
4. Bilirubin 2 times (or 3 times if the patient has Gilbert syndrome) or less than the upper limit of normal.
5. AST 3 times or less than the upper limit of normal.
6. Estimated GFR \> 70 mL/min.
7. Pulse oximetry of \> 90% on room air
8. EKG shows no significant arrhythmias
9. Karnofsky or Lansky score of \> 60%.
10. Available allogeneic T cells with ≥15% expression of CD30CAR determined by flow-cytometry.
11. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy.
12. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
13. Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given a copy of the informed consent form.

Exclusion Criteria:

1. Received an investigational cell therapy or vaccine within the past 6 weeks.
2. Received an investigational small molecule drug within the past 2 weeks.
3. Received CD30 antibody-based therapy within the previous 4 weeks.
4. Received gemcitabine-containing chemotherapy within the previous 12 weeks
5. History of hypersensitivity reactions to murine protein-containing products.
6. Pregnant or lactating.
7. Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion).
8. Current use of systemic corticosteroids at a dose equivalent to higher than 10 mg/day of prednisone.
9. Active significant, uncontrolled bacterial, viral or fungal infection.
10. Symptomatic cardiac disease (NYHA Class III or IV disease).