B Hücreli Kanseri Olan Yetişkinlerde Damar İçi Allojenik Kimerik Antijen Reseptörlü Doğal Öldürücü Hücreler (CAR NK) — NKX019

Sade dilde özet

Bu Faz 1 (Phase 1) çalışma, CD19 hedefli allojenik CAR NK (doğal öldürücü, natural killer) hücrelerinden oluşan deneysel NKX019 tedavisinin güvenliliğini ve tolere edilebilirliğini araştıran tek kollu, açık etiketli ve çok merkezli bir çalışmadır. Çalışmaya nükseden veya tedaviye dirençli non-Hodgkin lenfoma (NHL), kronik lenfositik lösemi (KLL) ya da B hücreli akut lenfoblastik lösemi (B-ALL) hastaları alınmaktadır. Katılım için ECOG performans durumunun 1 veya daha iyi olması ve DSÖ 2016 sınıflamasına göre histolojik veya sitolojik olarak doğrulanmış tanı bulunması 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

Nkarta, Inc.

Müdahale

NKX019

Başlangıç

20.08.2021

Tahmini bitiş

01.12.2038

Ülkeler

United States, Australia

Merkezler

• Denver, United States
• Cleveland, United States
• Camperdown, Australia
• Sydney, Australia
• Brisbane, Australia
• Melbourne, Australia

Uygunluk kriterleri

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

Inclusion Criteria:

General:

Eastern Cooperative Oncology Group (ECOG) performance status ≤1

• Disease Related:

* Have a histologically or cytologically confirmed diagnosis of r/r B cell NHL or CLL or B-ALL as defined by WHO 2016 classification
* Subjects who received prior CD19/CD20-directed therapy must have disease that remains CD19+ and/or CD20+ respectively
* Have measurable disease
* Have received ≥2 lines of therapy except subjects with MCL, CAR T Naïve cohorts and WM, who must have received at least 1 prior line of therapy
* Have received a combination of an anti CD20 monoclonal antibody and cytotoxic chemotherapy for subjects with NHL
* Received:

  * BTKi for subjects with MCL, CLL/SLL, WM, and other indications where a BTKi is approved
  * Venetoclax for subjects with CLL/SLL
  * Tyrosine kinase inhibitor for subjects with Philadelphia chromosome (Ph+) B-ALL
* Not responded or relapsed within 12 months of completion of their prior line of therapy, with the exception of a newly diagnosed Richter's transformation of CLL/SLL or other transformation of an indolent lymphoma, including from WM
* Subjects must not have evidence of rapidly progressive disease that would preclude subject from completing at least 1 cycle of treatment.
* Adequate organ function
* White blood cell count of ≤20 × 109/L
* Platelet count ≥30,000/uL

Exclusion Criteria:

• Disease related:

* Burkitt Lymphoma, primary central nervous system (CNS) lymphoma, Richter's transformation to Hodgkin lymphoma
* Subjects with WM who underwent plasmapheresis \<35 days prior to the first dose of NKX019
* Subjects with NHL with any evidence of active CNS malignancy
* Subjects with B-ALL who have extramedullary disease (EMD)
* Subjects with any prior cellular therapy except subjects enrolling in selected cohorts who must have received prior CAR T therapy, recent HCT, or complications from HCT
* Recent use of any cancer-directed therapy within protocol specified window prior to the first dose of NKX019
* Residual toxicities ≥Grade 2 due to prior therapy
* Other comorbid conditions and concomitant medications prohibited as per study protocol
* Pregnant or lactating female