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CAR T-cell Therapy
WU-NK-101 for Acute Myeloid Leukemia
Phase 1
Recruiting
Research Sponsored by Wugen, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial tests a new drug to fight acute myeloid leukemia in adults. It looks at safety, how it works, and if it's effective.
Who is the study for?
This trial is for adults with Acute Myeloid Leukemia (AML) that has returned after treatment or hasn't responded to previous treatments. Participants should have had a stem cell transplant over 90 days ago, no severe organ disease, and an ECOG Performance Status of ≤2. They can't join if they have severe kidney issues, high blast counts without reduction therapy, uncontrolled infections or heart problems, recent investigational drug use, known allergies to study drugs, or are pregnant/nursing.Check my eligibility
What is being tested?
The trial tests WU-NK-101's safety and effectiveness in treating AML that's come back or isn't responding to other treatments. It's an early-phase study where researchers gradually increase the dose to find the safest amount that works while monitoring how it affects the body and leukemia.See study design
What are the potential side effects?
While specific side effects of WU-NK-101 aren't listed here as it’s a new treatment under investigation, common side effects for similar leukemia therapies may include fatigue, fever, nausea and vomiting; potential risks will be closely monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events of WU-NK-101 as assessed by CTCAE v5
Maximum Tolerated Dose
Secondary outcome measures
Duration of Response
Overall Response Rate (ORR)
Overall Survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental: WU-NK-101Experimental Treatment1 Intervention
A non-engineered Natural Killer (NK) cell derived from peripheral blood mononuclear cells (PBMC) that is cytokine-reprogrammed, expanded, and cryopreserved to create an allogeneic enhanced Memory-like anti-tumor NK cell therapy product.
Each 28-day cycle of treatment consists of 3 doses of WU-NK-101 administered on Day 1, Day 8, and Day 15.
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Who is running the clinical trial?
Wugen, Inc.Lead Sponsor
5 Previous Clinical Trials
172 Total Patients Enrolled
Jan Davidson, MD, PhDStudy DirectorWugen, Inc.
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and am up and about more than half of my waking hours.My recent lung scans show new worsening spots.My kidneys are not working well, with a creatinine clearance below 40 mL/min.My condition is a type of leukemia, but not acute promyelocytic leukemia.I do not have any untreated serious infections.My leukemia has returned after a period of complete remission.I do not have severe heart issues like uncontrolled chest pain or irregular heartbeats.My AML has spread to my brain or spinal cord, but I meet certain conditions.My organs are working well.I have AML and have undergone a stem cell transplant.I have cancer outside the bone marrow but my bone marrow is still affected.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: WU-NK-101
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.
Has Experimental: WU-NK-101 received regulatory authorization from the FDA?
"Due to the limited amount of data on Experimental: WU-NK-101's safety and efficacy, our team at Power has estimated its safety rating as a 1."
Answered by AI
How many healthcare centers in Canada are administering this clinical research?
"The University of Maryland in Baltimore, Washington University in Saint Louis and Providence Portland Medical Center are the main clinical trial sites running this experiment. Furthermore, 6 additional medical centres have been recruited to support its execution."
Answered by AI
Is recruitment for this experiment still ongoing?
"The clinical trial, published on July 1st 2023 and last modified on April 5th 2023, is no longer recruiting participants. However, there are 1554 other studies that are currently in need of patient volunteers."
Answered by AI
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