Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

NCT05020678 : A Phase 1 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With B-cell Malignancies

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaAcute Lymphoblastic Leukaemia,B-Cell Non Hodgkin Lymphoma,Chronic Lymphocytic Leukaemia,Leukaemia,Lymphoma,Mantle Cell Lymphoma

Trial Overview Read MoreRead more

This phase I trial is trying to understand how safe and tolerable a new targeted therapy (NKX019) is in people with relapsed or refractory non-Hodgkin lymphoma, chronic lymphocytic leukaemia or B-cell acute lymphoblastic leukaemia .
 

This trial is treating patients with large B cell lymphoma, mantle cell lymphoma, indolent lymphoma, Waldenström macroglobulinemiam, chronic lymphocytic leukaemia/small lymphocytic lymphoma, and B-cell acute lymphoblastic leukaemia.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 1 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With B-cell Malignancies

Commercial Sponsor

Nkarta Inc

Summary

This is a dose-finding study that has two parts. In Part 1 (dose finding), a "3+3" enrolment schema will be utilised. In Part 2 (dose expansion), the safety and tolerability, cellular kinetics, pharmacodynamics and anti-tumour response will be further evaluated in expansion cohorts of participants with large B cell lymphoma (LBCL), mantle cell lymphoma (MCL), indolent lymphoma (IL), Waldenström macroglobulinemia (WM), CLL/ small lymphocytic lymphoma (SLL), and B-ALL. All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by 3 weekly doses of NKX019 on Day 0, 7, and 14 of a 28-day cycle. NKX019 is an investigational allogeneic CAR NK product targeting CD19 on cells. The starting dose of NKX019 in Part 1 is 3 × 10^8 NK cells (2 × 10^6/kg for patients < 50="" kg)="" administered="" as="" 3="" weekly="" doses.="" part="" 2="" will="" use="" the="" maximum="" tolerated="" dose="" (mtd)="" or="" recommended="" phase="" 2="" dose="" (rp2d)="" of="" nkx019="" as="" determined="" in="" part="">

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Felicity McLeay
PCCTU.HaemB@petermac.org

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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