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RecruitingLast updated: 5 February 2024

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.

Conditions

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

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

Trial Acronym

NKARTA

More information

Trial Identifiers

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Trial 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

  • General:

    • ECOG performance status ≤2
  • Disease related:

    • For AML subjects:

      • Previously treated relapsed/refractory AML, including subjects with MRD+ disease
      • Received at most 3 lines of previous anti-leukemia therapy
      • For subjects with targetable fms-like tyrosine kinase 3 (FLT3)-mutated or isocitrate dehydrogenase (IDH)1/2 mutated disease, subjects must have received at least 1 prior respective targeted therapy and may receive up to 4 lines of prior therapy
      • White blood cell count of ≤25 × 10^9/L
      • For groups receiving NKX101 after lymphodepletion with fludarabine/cyclophosphamide +/- decitabine: Disease localized to the bone marrow, as evidenced by ≤ 5% peripheral blasts and no evidence of extramedullary disease
      • For groups receiving NKX101 after lymphodepletion with fludarabine/ cyclophosphamide +/- decitabine, group receiving NKX101 after lymphodepletion with fludarabine/ara-C: Additional subjects with specifically high-risk genetic mutations may be enrolled. High risk genetic mutation per ELN 2022 should be evaluated as per local assay and discussed with the Sponsor prior to study entry
      • For groups receiving NKX101 after lymphodepletion with fludarabine/cyclophosphamide +/- decitabine, group receiving NKX101 after lymphodepletion with fludarabine/ara-C: Additional subjects who have relapsed following HCT may be enrolled.
    • For MDS subjects:

      • Intermediate-, high-, or very high-risk MDS
      • Previously treated relapsed/refractory MDS
      • Received at least 1 and at most 3 lines of previous standard anti-MDS therapy
      • For groups receiving NKX101 after lymphodepletion with fludarabine/ cyclophosphamide +/- decitabine: Additional subjects with specifically high-risk disease may be enrolled. High-risk genetic mutation should be evaluated as per local assay
      • For group receiving lymphodepletion with fludarabine/cyclophosphamide +/- decitabine and NKX101: Additional subjects who have relapsed following HCT may be enrolled.
  • Adequate Organ Function
  • Platelet count ≥30,000/uL (platelet transfusions acceptable)
  • Other:

    • Signed informed consent
    • Agree to use an effective barrier method of birth control

Exclusion

  • Disease related:

    • Acute promyelocytic leukemia with t(15;17) (q22;q12); or abnormal promyelocytic leukemia/retinoic acid receptor alpha (APML-RARA) and AML arising from chronic myelomonocytic leukemia (CMML)
    • Evidence of leukemic meningitis or known active central nervous system disease
    • Peripheral leukocytosis with ≥ 20,000 blasts/μL or other evidence of rapidly progressive disease that would preclude subject from completing at least 1 cycle of treatment
    • Use of any anti-AML/MDS chemotherapeutic or targeted small molecule drug within protocol specified window prior to the first dose of NKX101
    • Presence of residual non-hematologic toxicity from prior therapies that has not resolved to ≤ Grade 1
    • Any hematopoietic cell transplantation within 16 weeks
  • Other comorbid conditions and concomitant medications prohibited as per study protocol
  • Other:

    • Pregnant or lactating female

Inclusion

  • 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.

Exclusion

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

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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