< 50="" kg)="" administered="" as="" 3="" weekly="" doses.="" the="" starting="" dose="" of="" nkx101="" in="" part="" 1/regimen="" b="" is="" 1.5="" ã—="" 10^8="" nk="" cells="" (3="" ã—="" 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="" 1."="">

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RecruitingLast updated:15 August 2023

NKARTA: This Phase I trial is evaluating how safe and tolerable an experimental targeted therapy (NKX101) is in people with acute myeloid leukaemia or myelodysplastic syndromesA Phase 1 Study of NKX101, an Activating Chimeric Receptor Natural Killer Cell Therapy, in Subjects With Hematological Malignancies or Dysplasias

Clinical summary

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="" ã—="" 10^8="" nk="" cells="" (3="" ã—="" 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="">

Treatment Type

Systemic therapy (chemotherapy, hormone therapy or immunotherapy)

Age

People18+

Phase

I

Trial Acronym

NKARTA

More information

Trial Identifiers

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Commercial Sponsor

Nkarta Inc.

Scientific Title

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

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Exclusion

  • 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.
Message

Clinical trials have complex eligibility criteria.

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