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NK Cell Therapy for Acute Myeloid Leukemia (CYNK001AML01 Trial)
CYNK001AML01 Trial Summary
This trial will study the safety and effectiveness of a new leukemia treatment that usesNK cells.
CYNK001AML01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCYNK001AML01 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CYNK001AML01 Trial Design
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Who is running the clinical trial?
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- I can perform daily activities with minimal assistance.I have been diagnosed with bi-phenotypic acute leukemia.I had a bone marrow transplant less than 60 days ago or plan to have one within 28 days after my first CYNK-001 infusion.I have been diagnosed with acute promyelocytic leukemia.I am between 18 and 80 years old.I have severe asthma or another lung condition and am on long-term medication.My organs are not functioning properly.My AML has returned after at least one complete remission, including after a stem cell transplant.I am not pregnant and agree to use birth control during and for 28 days after treatment.My latest bone marrow test shows minimal residual disease.I agree to use a condom for 28 days after my last CYNK-001 infusion.I haven't had cancer treatment with biologic agents in the last week.I do not have severe organ problems that would affect my treatment.I have an autoimmune disease but it's under control and I'm not on active treatment.My AML is in the first or second complete remission or almost in remission.I can stop taking immunosuppressive drugs for 3 days before my treatment, except for low-dose steroids.I have AML that developed from MDS and have had at least one treatment for it.My AML did not respond to at least 2 initial treatments.I have been cancer-free for over 3 years, except for AML, MDS, or MPN.I haven't had any untreated infections or taken antibiotics for an uncontrolled infection in the last 2 weeks.My brain or spinal cord cancer has been treated and is clear for at least 2 weeks.I have AML from previous cancer treatments and have had at least one treatment for it.I have new or worsening lung issues visible on an x-ray or CT scan within 2 weeks of starting CYNK-001 treatment.I haven't been part of a clinical trial or received any experimental treatments in the last 28 days.My heart's pumping ability is below 40%.My condition relapsed or is resistant after initial treatment, confirmed by a pathology report.
- Group 1: Dose escalation/MTD or MPD determination in Relapsed/Refractory AML patients
- Group 2: Dose escalation/MTD or MPD determination in MRD positive AML patients
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there still opportunities to join this experiment?
"Affirmative. Clinicaltrials.gov indicates that this investigation is currently searching for research participants, with the trial having been initially uploaded on March 12th 2020 and most recently adjusted on September 9th 2022. 94 people have to be recruited from across nine sites."
Are there any historical precedents of employing CYNK-001 in clinical research?
"Presently, there is one CYNK-001 trial actively in progress with no Phase 3 trials. Buffalo, New york houses the majority of these studies; however 10 sites across the nation are running clinical trails for this drug."
Is the protocol for this research endeavor unprecedented?
"Presently, CYNK-001 has one active trial across 9 urban centres and 1 nation. The inaugural clinical study began in 2020 under the sponsorship of Celularity Incorporated, involving 94 patients that concluded Phase 1 drug approval. Since then, no further research projects have been completed."
What primary objective is this investigation attempting to attain?
"Celularity Incorporated, the trial sponsor, has established a Day +28 time frame to measure the primary outcome of Maximum Tolerated Dose (MTD) or Maximum Planned Dose (MPD). Furthermore, secondary objectives such as Overall Survival (OS), Time to Progression (TTP), and Number Participants who experience Minimal Residual Disease (MRD) Response are being evaluated. OS is defined as Date of first CYNK-001 infusion to date of death., while TTP is recorded between Date of first CYNK-001 infusion to date of disease progression in the MRD positive arm.. Finally, MRD"
Under what conditions may individuals participate in this clinical trial?
"To partake in this research, patient's must be aged 18-80 and have a hematologic disorder. Currently, 94 people are being enrolled into the trial."
Is this clinical trial being conducted broadly throughout the city?
"Patients can enroll in this medical study at Westchester Medical Center located in Valhalla, TX; MD Anderson Cancer Center located in Houston, WA; and Swedish Health Services situated in Seattle, CO as well as 9 other sites."
Does this research involve participants aged twenty or more?
"Consistent with the qualifications for this trial, individuals aged 18 and over and below 80 are eligible to take part."
Has CYNK-001 received clearance from the FDA?
"As this is a Phase 1 trial, there are limited data supporting the safety and efficacy of CYNK-001. Therefore, our team at Power have assigned it a score of 1 on a scale from one to three."
What is the overall enrolment count for this experiment?
"To carry out this medical study, 94 willing participants who satisfy the established criteria must be recruited. The trial is taking place at two sites: Westchester Medical Center in Valhalla, Texas and MD Anderson Cancer Centre in Houston, Washington."
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