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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed diagnosis of r/r B cell NHL or CLL or B-ALL as defined by WHO 2016 classification
Received Tyrosine kinase inhibitor for subjects with Philadelphia chromosome (Ph+) B-ALL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up primary assessment: 28 days after first dose of nkx019 followed up to 2 years after last dose of nkx019
Awards & highlights
Study Summary
This trial is testing a new therapy called NKX019 (allogeneic CAR NK cells targeting CD19) to see if it is safe and tolerable for patients with relapsed/refractory non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) or B cell acute lymphoblastic leukemia (B-ALL).
Who is the study for?
Adults with certain B-cell cancers like non-Hodgkin lymphoma, chronic lymphocytic leukemia, or acute lymphoblastic leukemia that have come back or didn't respond to treatment can join. They must have had at least two prior treatments (one for some cases), be in fairly good health, and not pregnant. People with active brain cancer, recent other cancer treatments, or specific types of lymphoma aren't eligible.Check my eligibility
What is being tested?
The trial is testing NKX019, a new type of cell therapy using modified natural killer cells aimed at CD19 on cancer cells. It's an early-phase study to see if it's safe and how well patients tolerate it. All participants receive the same experimental treatment without a comparison group.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune response such as fever and fatigue, organ inflammation due to targeted cell destruction by the therapy, infusion-related reactions from the actual process of receiving the cells intravenously.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis is a type of B cell blood cancer, as confirmed by lab tests.
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I have taken medication for leukemia that targets specific proteins.
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My cancer still shows CD19 or CD20 positivity after previous treatments targeting these.
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I am fully active and can carry on all pre-disease activities without restriction.
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My cancer can be measured by tests.
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I have been treated with a specific antibody and chemotherapy for my lymphoma.
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I have taken Venetoclax for my CLL/SLL.
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I have been treated with a BTK inhibitor for my cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ primary assessment: 28 days after the first dose of nkx019 followed up to 2 years after the last dose of nkx019]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~primary assessment: 28 days after the first dose of nkx019 followed up to 2 years after the last dose of nkx019]
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Objective response rate to NKX019 in Part 2
Proportion of subjects experiencing dose-limiting toxicities of NKX019
Secondary outcome measures
Assessment of NKX019 half-life
Evaluation of host immune response against NKX019
NKX019 duration of persistence
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: NKX019 - CAR NK cell therapyExperimental Treatment1 Intervention
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. Combination cohorts (if opened) will additionally receive rituximab with each cycle.
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Who is running the clinical trial?
Nkarta Inc.Lead Sponsor
1 Previous Clinical Trials
61 Total Patients Enrolled
David Shook, MDStudy DirectorNkarta Inc.
3 Previous Clinical Trials
97 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had cellular therapy, except for specific approved types.My condition is stable enough to complete at least one treatment cycle.I have Waldenstrom's macroglobulinemia and had plasmapheresis less than 35 days ago.I haven't had cancer treatment within the specified time before starting NKX019.My condition is either Burkitt Lymphoma, primary CNS lymphoma, or has transformed to Hodgkin lymphoma.My condition worsened or didn't improve within 12 months after my last treatment.My organs are working well.I have lasting side effects from previous treatments that are moderate to severe.Your white blood cell count is less than or equal to 20 times 10 to the power of 9 per liter.I have non-Hodgkin lymphoma with signs of cancer in my brain or spinal cord.My leukemia has spread outside of my bone marrow.My diagnosis is a type of B cell blood cancer, as confirmed by lab tests.I have taken medication for leukemia that targets specific proteins.You have a platelet count of at least 30,000 per microliter of blood.My cancer still shows CD19 or CD20 positivity after previous treatments targeting these.I am fully active and can carry on all pre-disease activities without restriction.I am not on any medications or have conditions that the study does not allow.I have had at least 2 treatments for my condition, except if I have MCL, CAR T Naïve, or WM, then at least 1.My cancer can be measured by tests.I have been treated with a specific antibody and chemotherapy for my lymphoma.I have taken Venetoclax for my CLL/SLL.I have been treated with a BTK inhibitor for my cancer.
Research Study Groups:
This trial has the following groups:- Group 1: NKX019 - CAR NK cell therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals currently being accepted to partake in this clinical trial?
"This research study, which was initially published on August 20th 2021, is still actively searching for participants. Recent updates to the information were made January 19th 2022."
Answered by AI
What are the principal aims of this research?
"According to the study sponsor, Nkarta Inc., one of the primary objectives being evaluated is safety and tolerability during a 28-day period post first dose. Additionally, NKX019's half life reduction rate, duration of persistence in peripheral blood, and objective response rate will be analyzed as secondary outcomes. To measure such metrics, Lugano classification (with LYRIC refinement for NHL cases) 2018 iwCLL guidelines for CLL/SLL patients, Version 1.2020 NCCN criteria for B-ALL sufferers and consensus criteria from 6th International Workshop on Waldenström Macroglobulinem"
Answered by AI
What is the scale of this experiment in terms of participant numbers?
"Affirmative. Clinicaltrial.gov displays that this research, initially published on August 20th 2021 is actively recruiting volunteers. 60 participants need to be sourced from 3 distinct medical sites."
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Has the regulatory body given clearance to NKX019?
"NKX019's safety score is assessed to be 1 due to its Phase 1 designation, as there is only minimal data proving its efficacy and security."
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