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CAR T-cell Therapy

CAR NK Cell Therapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 1
Waitlist Available
Research Sponsored by Nkarta Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Received at least 1 and at most 2 lines of previous standard anti-MDS therapy
Haplo-matched related subjects require a suitable haplo-matched related donor, who is able and willing to undergo leukapheresis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up primary assessment: 28 days after first dose of nkx101 followed up to 2 years after last dose of nkx101
Awards & highlights

Study Summary

This trial is testing a new therapy called NKX101 that uses a patient's own immune cells to target and kill cancer cells. The trial will test the safety and tolerability of NKX101 in patients with relapsed or refractory leukemia or myelodysplastic syndrome.

Who is the study for?
This trial is for adults with relapsed/refractory Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndromes (MDS). Participants must have had 1-2 prior treatments, a white blood cell count ≤25 × 10^9/L, and platelets ≥30,000/uL. They need functioning organs and an ECOG status ≤2. A suitable donor for leukapheresis is required if haplo-matched. Birth control use is mandatory.Check my eligibility
What is being tested?
NKX101 - CAR NK cell therapy is being tested in this Phase 1 study to see how safe and tolerable it is for patients with AML or MDS that has come back or didn't respond to treatment. It's given intravenously and targets NKG2D ligands on cancer cells.See study design
What are the potential side effects?
While the specific side effects of NKX101 are not listed here, similar therapies can cause immune reactions, fatigue, fever, allergic responses to infused cells, organ inflammation, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had 1 or 2 treatments for myelodysplastic syndrome.
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I have a family member willing and able to donate stem cells.
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I have MDS that came back or didn't respond to treatment.
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I can take care of myself but might not be able to do heavy physical work.
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My MDS is classified as intermediate, high, or very high risk.
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My AML has returned or didn't respond to treatment, including if it's MRD+.
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I have had 1 or 2 treatments for leukemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~primary assessment: 28 days after first dose of nkx101 followed up to 2 years after last dose of nkx101
This trial's timeline: 3 weeks for screening, Varies for treatment, and primary assessment: 28 days after first dose of nkx101 followed up to 2 years after last dose of nkx101 for reporting.

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]
Response rate to NKX101 (for Part 2)
Secondary outcome measures
Assessment of NKX101 half-life
Evaluation of host immune response against NKX101
NKX101 duration of persistence
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: NKX101 - CAR NK cell therapyExperimental Treatment1 Intervention
All subjects in Part 1 will receive lymphodepletion with fludarabine/cyclophosphamide followed by 3 or 2 (Regimen A or B, respectively) weekly doses of NKX101. Subjects in Part 2 will receive lymphodepletion with either fludarabine/cyclophosphamide or fludarabine/cytarabine (ara-C), or if the optional arm is opened, lymphodepletion with fludarabine/cyclophosphamide and decitabine, followed by 3 weekly doses of NKX101. Part 2: unrelated off-the-shelf donor derived NKX101 will be used.

Find a Location

Who is running the clinical trial?

Nkarta Inc.Lead Sponsor
1 Previous Clinical Trials
150 Total Patients Enrolled
Minoti Hiremath, MD, PhDStudy DirectorNkarta Inc.
David Shook, MDStudy DirectorNkarta Inc.
3 Previous Clinical Trials
186 Total Patients Enrolled

Media Library

NKX101 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04623944 — Phase 1
Acute Myeloid Leukemia Research Study Groups: NKX101 - CAR NK cell therapy
Acute Myeloid Leukemia Clinical Trial 2023: NKX101 Highlights & Side Effects. Trial Name: NCT04623944 — Phase 1
NKX101 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04623944 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you name any healthcare facilities in this state which are participating in the clinical trial?

"This medical trial is enrolling patients from 7 various locations, including Nashville, Cleveland and Houston. To reduce necessary travel requirements, individuals are encouraged to pick the site closest to them should they decide to join this study."

Answered by AI

How many subjects are included in this experiment?

"Affirmative. Evidenced on clinicaltrials.gov, the study is presently recruiting and was first posted on September 21st 2020 with a subsequent update occurring April 8th 2022. 90 individuals are required between 7 sites for enrollment."

Answered by AI

What medical issues does NKX101 - CAR NK cell therapy most often address?

"NKX101-CAR NK cell therapy offers a therapeutic solution for multiple sclerosis, mixed-cell type lymphoma, and acute myelocytic leukemia."

Answered by AI

Is it possible to join this trial at present?

"Affirmative. Clinicaltrials.gov provides evidence that this investigation is actively recruiting participants, with the original posting having been made on September 21st 2020 and last updated April 8th 2022. 90 individuals are required to be recruited from 7 different medical facilities."

Answered by AI

What are the safety profiles associated with NKX101 - CAR NK cell therapy?

"The limited clinical data on NKX101 - CAR NK cell therapy indicates that it is likely safe, thus receiving a score of 1."

Answered by AI

Could you provide an overview of past experiments involving NKX101 - CAR NK cell therapy?

"Currently, 889 medical studies are being conducted on NKX101 - CAR NK cell therapy. Of the 161 trials currently in Phase 3, several of those clinical sites fall within Philadelphia, Pennsylvania. Moreover, 28446 different locations worldwide have registered to carry out testing for this cutting-edge treatment."

Answered by AI

What is the main purpose of this clinical trial?

"According to Nkarta Inc., the primary goal of this 28-day trial will be gauging response rate to NKX101 (Part 2). Secondary measurements include time-to-first response, duration of response, transfusion independence rate, bridge-to transplant success rates and event free survival. Additionally, hematologic improvement rates for subjects with myelodysplastic syndrome is being monitored as well as half-life reduction from maximum amount of circulating NKX101 and persistence testing every 3 months post dosing."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
NKX101, Intravenous Allogeneic CAR NK Cells, in Adults With AML or MDS
2020. "NKX101, Intravenous Allogeneic CAR NK Cells, in Adults With AML or MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04623944.
~3 spots leftby Jul 2024
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