Your session is about to expire
← Back to Search
CAR T-cell Therapy
Natural Killer Cell Therapy for Acute Myeloid Leukemia (KARMA Trial)
Phase 1 & 2
Recruiting
Led By Margaret Lamb, MD
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
KARMA Trial Summary
This trial is studying a natural killer cell therapy as a possible treatment for acute myeloid leukemia.
Who is the study for?
This trial is for young adults aged 18-24.99 with relapsed or refractory acute myeloid leukemia (AML). Participants must have stable organ function, controlled seizures if present, and no severe treatment-related side effects from previous therapies. They should not be pregnant, agree to use contraception post-treatment, and have no uncontrolled infections or cardiac issues.Check my eligibility
What is being tested?
The study tests the safety and potential effectiveness of Universal Donor Natural Killer (UD-NK) cells combined with FLA chemotherapy in patients with AML that has returned or didn't respond to initial treatments. It's a phase I/II trial where doses are adjusted to find the safest and most effective level.See study design
What are the potential side effects?
Possible side effects may include reactions related to immune cell infusion such as fever or chills, fatigue, risk of infection due to weakened immunity, nausea from chemotherapy, liver enzyme changes indicating stress on the liver, and potential impact on blood counts.
KARMA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of adverse events
Rate of dose limiting toxicities
Secondary outcome measures
CR rate after first cycle
Incidence of infectious complications
Transplantation
+4 moreOther outcome measures
Expansion/persistence of UD-NK cells after infusion
Function of UD-NK Cells
Immunophenotype of UD-NK cells
KARMA Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Fludarabine 30 mg/m2/day (day -6 to day -2) and Cytarabine 2000 mg/ m2/day (days -6 to day -2)
Six doses of universal donor IL-21 expanded NK cells (UD-NK) given thrice weekly for two weeks starting on day 0. Days may vary and NK cells can be given from days 0 to 21. Patients may receive up to 2 cycles of fludarabine/cytarabine (FLA) + NK cells (up to 12 NK cell infusions) if they do not achieve CR after cycle 1 or if necessary to bridge to transplant.
Find a Location
Who is running the clinical trial?
Nationwide Children's HospitalLead Sponsor
341 Previous Clinical Trials
5,220,483 Total Patients Enrolled
Margaret Lamb, MDPrincipal InvestigatorNationwide Children's Hospital
1 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is limited to the brain or outside the bone marrow.My seizures are well controlled with medication.I have not received a donor lymphocyte infusion in the last 30 days.I am currently on medication to suppress my immune system.My organs are functioning well.I need considerable assistance and medical care.I had a stem cell transplant from a donor less than 3 months ago.I currently have active graft-versus-host disease.I haven't taken any immune-weakening drugs for 2 weeks and don't have GVHD symptoms.I have heart rhythm problems or heart disease that is not under control.My AML has returned or did not respond to initial treatment.My kidney function is normal, with creatinine levels at or below 2 mg/dl or my creatinine clearance rate is above 60 ml/min.My gender or race does not exclude me from this trial.My heart pumps well enough, or I've been cleared by a cardiologist.I have a virus in my blood but no symptoms.My liver is functioning within the required limits, except for conditions like Gilbert's syndrome.Any side effects from my previous treatments are mild now.I haven't taken any AML treatments in the last 2 weeks, except for hydroxyurea.I agree to use effective birth control for 6 months after my last treatment.My AML did not respond to the first 2 chemotherapy treatments.I am between 18 and 24 years old.I have recovered from the side effects of my previous cancer treatments.My AML has returned after a stem cell transplant.I do not have an ongoing infection that is getting worse despite treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
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.
To what extent is the capacity of this study being extended?
"Affirmative, according to the information on clinicaltrials.gov this experimental trial is still actively recruiting patients. It was first introduced on February 14th 2022 and its details were last revised August 11th 2022. A total of 20 individuals are needed at a single medical centre."
Answered by AI
How can I participate in this clinical experiment?
"This trial seeks 20 participants suffering from acute myelocytic leukemia aged between 18 and 24 years old. To be eligible for the study, candidates must meet multiple criteria such as having relapsed AML after a stem cell transplantation, renal function of Creatinine ≤ 2 mg/dl OR creatinine clearance > 60 ml/min/1.73m2., Total bilirubin ≤ 2 mg/dl (unless Gilbert's syndrome), AST ≤ 150, ALT ≤108 (unless related to leukemic involvement), negative pregnancy test in females of childbearing potential within two weeks prior to enrollment, effective contraception use in"
Answered by AI
Does this trial extend its eligibility to senior citizens?
"This study is limited to individuals aged 18-24. Alternatively, those younger than the age of consent can gain access to 450 other trials while seniors over 65 are eligible for 1,231 different studies."
Answered by AI
Is the intake of participants for this medical experiment still open?
"The information on clinicaltrials.gov indicates that this trial is still open to participants. The protocol was initialised on February 14th 2022 and has been updated as recently as August 11th, 2022."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger