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CAR T-cell Therapy

CAR NK Cells for B-Cell Cancers

Phase 1

Recruiting

Research Sponsored by Nkarta, Inc.

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

Must not have

Burkitt Lymphoma, primary central nervous system (CNS) lymphoma, Richter's transformation to Hodgkin lymphoma

Residual toxicities ≥Grade 2 due to prior therapy

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

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition is either Burkitt Lymphoma, primary CNS lymphoma, or has transformed to Hodgkin lymphoma.

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I have lasting side effects from previous treatments that are moderate to severe.

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I have non-Hodgkin lymphoma with signs of cancer in my brain or spinal cord.

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My leukemia has spread outside of my bone marrow.

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]

This trial's timeline: 3 weeks for screening, Varies for treatment, and primary assessment: 28 days after the first dose of nkx019 followed up to 2 years after the last dose of nkx019] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Assessment of NKX019 half-life

Evaluation of host immune response against NKX019

NKX019 duration of persistence

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 12Eligibility criteria met