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RecruitingLast updated: 2 February 2024

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

Clinical summary

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 1.

Conditions

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

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Nkarta Inc

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

Eligibility

Inclusion

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

• 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

Inclusion

  • 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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