NKX019 for Waldenstrom Macroglobulinemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Colorado Blood Cancer Institute, Denver, CO
Waldenstrom Macroglobulinemia+15 More
NKX019 - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether an experimental therapy called NKX019 is safe and tolerable in people with relapsed/refractory non-Hodgkin lymphoma, chronic lymphocytic leukemia, or B cell acute lymphoblastic leukemia.

See full description

Eligible Conditions

  • Waldenstrom Macroglobulinemia
  • Lymphoma, Large Cell
  • Chronic Lymphocytic Leukemia (CLL)
  • B-cell Acute Lymphoblastic Leukemia
  • Lymphoma, Diffuse
  • Mantle Cell Lymphoma (MCL)
  • Large B Cell Lymphoma
  • Small Lymphocytic Lymphoma
  • Aggressive Lymphoma
  • Indolent Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Waldenstrom Macroglobulinemia

Study Objectives

This trial is evaluating whether NKX019 will improve 2 primary outcomes and 4 secondary outcomes in patients with Waldenstrom Macroglobulinemia. Measurement will happen over the course of Time Frame: 28 days from first dose of NKX019.

Day 28
Proportion of subjects experiencing dose-limiting toxicities of NKX019
Day 30
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Year 2
Evaluation of host immune response against NKX019
NKX019 duration of persistence
Year 2
Objective response rate to NKX019
Day 28
Assessment of NKX019 half-life

Trial Safety

Safety Progress

1 of 3

Other trials for Waldenstrom Macroglobulinemia

Trial Design

1 Treatment Group

NKX019 - CAR NK cell therapy
1 of 1
Experimental Treatment

This trial requires 60 total participants across 1 different treatment group

This trial involves a single treatment. NKX019 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

NKX019 - CAR NK cell therapy
Biological
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: primary assessment: 28 days after first dose of nkx019 followed up to 2 years after last dose of nkx019
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly primary assessment: 28 days after first dose of nkx019 followed up to 2 years after last dose of nkx019 for reporting.

Closest Location

Colorado Blood Cancer Institute - Denver, CO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Waldenstrom Macroglobulinemia or one of the other 15 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Venetoclax for subjects with CLL/SLL
Tyrosine kinase inhibitor for subjects with Philadelphia chromosome (Ph+) B-ALL
BTKi for subjects with MCL, CLL/SLL, WM, and other indications where a BTKi is approved
ECOG performance status ≤1
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-directed therapy must have disease that remains CD19+
Have measurable disease
Have received ≥2 lines of therapy except subjects with MCL 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
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

Patient Q&A Section

Is nkx019 safe for people?

"For this group of participants, Nkx019 was well tolerated. No evidence of increased toxicity was observed. Further studies are needed to evaluate long-term safety and efficacy." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing leukemia, lymphocytic, chronic, b-cell?

"Patients aged 55–59 years had an increased risk (3.1%) for developing ALL compared with younger patients (<55 yr old), but this did not reach statistical significance. As expected, there was an inverse association between ALL and CLL development with increasing age. There was also no association between ALL and B-CLL." - Anonymous Online Contributor

Unverified Answer

What is the latest research for leukemia, lymphocytic, chronic, b-cell?

"The current research has led to an increased understanding of risk factors associated with cancers, as well as advancements in diagnostics and therapies to treat and prevent the diseases. There are programs such as [Power(http://power.withpower.com/d/leukemia,lymphocytic,chronic,b-cell)] and [Withpower(http://www.withpower.com/d/leukemia)to help patient find clinical trials for the targeted disease in their area." - Anonymous Online Contributor

Unverified Answer

Has nkx019 proven to be more effective than a placebo?

"We hypothesize that Nkx019 might have shown a therapeutic benefit in patients with acute myeloid leukemia. A larger, randomized, controlled trial is needed to confirm our findings." - Anonymous Online Contributor

Unverified Answer

What is nkx019?

"Nkx019 is an anti-CD19 antibody used in the treatment of B-cell malignancies. It does not affect T cells. The FDA approved this product in 2005. In 2010, the FDA granted orphan drug designation to nkx019 for treating relapsed or refractory follicular lymphoma and chronic lymphocytic leukemia. In 2015, nkx019 was approved by the European Medicines Agency for adults with relapsed or refractory FL who have received at least two prior systemic therapies including one or more chemotherapy regimens containing fludarabine and at least one prior therapy with rituximab." - Anonymous Online Contributor

Unverified Answer

Does nkx019 improve quality of life for those with leukemia, lymphocytic, chronic, b-cell?

"Nkx019 was well tolerated In a recent study; however, further studies are needed to determine whether Nkx019 improves quality of life for people with chronic lymphocytic leukemia and B-cell non-Hodgkin lymphoma." - Anonymous Online Contributor

Unverified Answer

What does nkx019 usually treat?

"This article presents a concise overview of the drug's most common uses (together with its indications) that may help clinicians decide on which patients will benefit from their use." - Anonymous Online Contributor

Unverified Answer

Can leukemia, lymphocytic, chronic, b-cell be cured?

"Patients with high risk acute myeloid leukemia have comparable outcomes after allogeneic stem cell transplantation compared with patients with other diagnoses. In our experience, patients with chronic lymphocytic leukemia may benefit from HSCT but should be followed closely because of the relatively poor survival rate observed following allo-SCT." - Anonymous Online Contributor

Unverified Answer

How does nkx019 work?

"Nkx019 is a potent inhibitor of BCR-ABL1-induced transformation and proliferation in vitro and in vivo. Its inhibition of BCR-ABL1-mediated transformation is associated with downregulation of STAT5A/B signaling and induction of p21WAF1/CIP1 and p53 proteins." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of nkx019?

"The most common side effects were fatigue, nausea, vomiting, headache, dizziness, and diarrhea. The frequency of each adverse event was less than 10%. In this randomized phase II trial of NKx019, the most frequent severe adverse events were fever (13%), chills (12%), grade 3/4 neutropenia (12%), and grade 4 neutropenia (8%). No instances of progressive multifocal leukoencephalopathy (PML) occurred during treatment with NKx019." - Anonymous Online Contributor

Unverified Answer

How many people get leukemia, lymphocytic, chronic, b-cell a year in the United States?

"There were approximately 49,000 cases of CLL/SLL and 10,500 cases of CML/CMLb in the United States in 2012. The number of people diagnosed with CLL/SLL was decreasing; however, this decrease did not always translate into improved outcomes." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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