Your session is about to expire
← Back to Search
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 up to 24 months
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of a new treatment for advanced myeloid neoplasms.
Who is the study for?
Adults over 18 with advanced myeloid neoplasms, specifically relapsed or refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) after treatment failure, or Chronic myelomonocytic leukemia (CMML). Participants must have an ECOG performance status of 0-2 and a life expectancy of at least 12 weeks. They should not be pregnant or planning to conceive and must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the safety, tolerability, and efficacy of NC525 in patients with advanced myeloid neoplasms. It's an open-label, non-randomized Phase 1 study which means everyone gets the drug being tested and there are no placebo groups.See study design
What are the potential side effects?
Specific side effects for NC525 aren't listed but may include typical reactions to immunotherapy such as allergic responses, fatigue, fever, chills, weakness, nausea/vomiting. Since it's a study determining safety/tolerability these will be closely monitored.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Define a maximum tolerated dose (MTD) of NC525
Define a minimally active dose (MAD) of NC525
Define a pharmacologically active dose (PAD) of NC525
+3 moreSecondary outcome measures
Area under the serum concentration versus time curve (AUC) of NC525
Assessment of time to achieve response, defined as CR, CRi, or CRh
Maximum Observed Serum Concentration (Cmax) of NC525
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: NC525Experimental Treatment1 Intervention
Escalating dose levels will be explored.
Find a Location
Who is running the clinical trial?
NextCure, Inc.Lead Sponsor
6 Previous Clinical Trials
485 Total Patients Enrolled
Han Myint, MDStudy DirectorNextCure, Inc.
4 Previous Clinical Trials
326 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to my brain or spinal cord.I have a relapsed or refractory form of AML, MDS, or CMML.I have lasting side effects from a bone marrow transplant.I am a male and agree to use contraception and not donate sperm for 90 days after treatment.I am able to get out of my bed or chair and move around.I have an infection that hasn't improved with treatment.I had a stem cell transplant from a donor within the last 6 months.I have been diagnosed with a specific type of leukemia.I need oxygen all the time due to a lung condition or other illness.I do not have another cancer that is getting worse or needs treatment, nor have I been treated for another cancer in the last 2 years.I have no significant health issues apart from my current condition.I have not taken medication for graft-versus-host disease in the last 4 weeks.I have not received a live vaccine in the last 30 days.I have a significant brain or nervous system condition.I am not pregnant, not breastfeeding, and either use birth control or cannot become pregnant.I have an ongoing severe reaction from a transplant.I do not have active hepatitis B or C, or if I do, my viral load has been undetectable for 3 months.I am 18 years old or older.I have been diagnosed with HIV.My organs are functioning well.I have undergone CAR-T therapy before.I had a stem cell transplant using my own cells within the last 6 weeks.I still have significant side effects from my previous treatments.I have received an organ transplant from another person.
Research Study Groups:
This trial has the following groups:- Group 1: NC525
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.
Is NC525 a viable option for people with regards to safety?
"The safety profile of NC525 was assigned a score of 1 due to its Phase 1 designation, indicating that there is limited data available regarding its efficacy and security."
Answered by AI
Are there still openings available for this medical experiment?
"The clinical trial page on clinicialtrials.gov affirms that this research is recruiting participants. It was posted initially on February 28th 2023 and has seen its most recent update March 14th of the same year."
Answered by AI
How many individuals are currently taking part in this research endeavor?
"Affirmative. According to clinicaltrials.gov, the mentioned medical trial is still recruiting participants since it was first posted on February 28th 2023 and last edited on March 14th 2023. The study requires 63 individuals from two separate sites for enrollment."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger