Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
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 people with large B cell lymphoma, mantle cell lymphoma, indolent lymphoma, Waldenström macroglobulinemiam, chronic lymphocytic leukaemia/small lymphocytic lymphoma, and B-cell acute lymphoblastic leukaemia
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 come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
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
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