NKARTA : A Phase 1 Study of NKX101, an Activating Chimeric Receptor Natural Killer Cell Therapy, in Subjects With Hematological Malignancies or Dysplasias

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 Myeloid Leukaemia,Myelodysplasia

Trial Overview Read MoreRead more

This Phase I trial is evaluating how safe and tolerable an experimental targeted therapy (NKX101) is in people with acute myeloid leukaemia or myelodysplastic syndromes.
 

This trial is treating patients with relapsed/refractory acute myeloid leukaemia or intermediate, high and very high risk relapsed/refractory myelodysplastic syndromes.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.
  • 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 NKX101, an Activating Chimeric Receptor Natural Killer Cell Therapy, in Subjects With Hematological Malignancies or Dysplasias

Commercial Sponsor

Nkarta Inc.

Summary

This trial has one experimental arm with two parts. Part 1 is a dose-finding phase with two dosing regimens, utilizing modified "3+3" enrolment schema. Either haplo-matched related donor derived or unrelated off-the-shelf donor derived NKX101 will be used. Part 2 is a dose expansion phase to further evaluate safety and tolerability, cellular kinetics, pharmacodynamics and anti-tumour response in expansion cohorts of patients. Either haplo-matched related donor derived or unrelated off-the-shelf donor derived NKX101 will be used. NKX101 is an investigational allogeneic CAR NK product targeting NKG2D ligands on cancer cells. The starting dose of NKX101 in Part 1/Regimen A is 1 × 10^8 NK cells (2 × 10^6/kg for patients < 50="" kg)="" administered="" as="" 3="" weekly="" doses.="" the="" starting="" dose="" of="" nkx101="" in="" part="" 1/regimen="" b="" is="" 1.5="" ×="" 10^8="" nk="" cells="" (3="" ×="" 10^6/kg="" for="" patients="">< 50="" kg)="" administered="" as="" 2="" weekly="" doses.="" part="" 2="" will="" use="" the="" maximum="" tolerated="" dose="" (mtd)="" or="" recommended="" phase="" 2="" dose="" (rp2d)="" of="" nkx101="" as="" determined="" in="" part="">

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

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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