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NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With B-cell Cancers
This is a single arm, open-label, multi-center, Phase 1 study to determine the safety and tolerability of an experimental therapy called NKX019 (allogeneic CAR NK cells targeting CD19) in patients with relapsed/refractory non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) or B cell acute lymphoblastic leukemia (B-ALL).
Study details:
This is a dose-finding study of NKX019 and will be conducted in 2 parts:. Part 1: dose finding utilizing a "3+3" enrollment schema and safety lead-in to confirm dose for NKX019 in combination with rituximab expansion cohorts (as applicable) Part 2: dose expansion to further evaluate safety and tolerability, cellular kinetics, pharmacodynamics and anti-tumor response in expansion cohorts of patients with large B cell lymphoma (LBCL), mantle cell lymphoma (MCL), indolent lymphoma (IL), Waldenström macroglobulinemia (WM), CLL/ small lymphocytic lymphoma (SLL), and B-ALL.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2021-08-20
Primary completion: 2024-08-01
Study completion finish: 2038-12-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05020678
Intervention or treatment
BIOLOGICAL: NKX019
Conditions
- • Lymphoma, Non-Hodgkin
- • B-cell Acute Lymphoblastic Leukemia
- • Large B-cell Lymphoma
- • Mantle Cell Lymphoma
- • Chronic Lymphocytic Leukemia
- • Small Lymphocytic Lymphoma
- • Indolent Lymphoma
- • Waldenstrom Macroglobulinemia
- • Aggressive Lymphoma
- • Large-cell Lymphoma
Find a site
Closest Location:
St. Vincent's Hospital
Research sites nearby
Select from list below to view details:
St. Vincent's Hospital
Sydney, New South Wales, Australia
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia
Institute of Haematology, Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Royal Brisbane and Woman's Hospital
Brisbane, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: NKX019 - CAR NK cell therapy
| BIOLOGICAL: NKX019
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence, nature, and severity of treatment related adverse events will be evaluated. An adverse event is any unfavorable and unintended sign including clinically significant abnormal laboratory findings, symptom or disease. | 30 days after last dose of NKX019 |
Proportion of subjects experiencing dose-limiting toxicities of NKX019 | DLTs are defined as adverse events attributable to NKX019 treatment that occur during Cycle 1 and meet protocol-specified criteria | 28 days from first dose of NKX019 |
Objective response rate to NKX019 in Part 2 | Percentage of subjects with complete and partial response. Response to treatment will be assessed based on: Lugano classification with LYRIC refinement for subjects with NHL (except CLL/SLL and WM); 2018 iwCLL guidelines for subjects with CLL/SLL; Version 1.2020 NCCN for subjects with B-ALL; consensus criteria from the 6th International Workshop on Waldenström Macroglobulinemia for subjects with WM. | Primary assessment: 28 days after the first dose of NKX019 followed up to 2 years after the last dose of NKX019] |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Assessment of NKX019 half-life | Time required for 50% reduction from maximum amount of circulating NKX019 | Time Frame: 28 days from first dose of NKX019 |
NKX019 duration of persistence | Testing NKX019 in peripheral blood every 3 months after dosing to determine persistence | Followed up to 2 years after last dose of NKX019 |
Evaluation of host immune response against NKX019 | Serum samples will be measured for antibodies against NKX019 | Followed up to 2 years after last dose of NKX019 |
Objective response rate to NKX019 in Part 1 | Percentage of subjects with complete and partial response. Response to treatment will be assessed based on: Lugano classification with LYRIC refinement for subjects with NHL (except CLL/SLL and WM); 2018 iwCLL guidelines for subjects with CLL/SLL; Version 1.2020 NCCN for subjects with B-ALL; consensus criteria from the 6th International Workshop on Waldenström Macroglobulinemia for subjects with WM. | Primary assessment: 28 days after first dose of NKX019 followed up to 2 years after last dose of NKX019 |
Frequently Asked Questions
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