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Cytokine
NT-I7 for Kaposi Sarcoma
Phase 1
Waitlist Available
Led By Thomas S. Uldrick, MD, MS
Research Sponsored by Fred Hutchinson Cancer Research Center
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 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial studies NT-I7, a lab-made substance that helps the immune system fight cancer, in patients with Kaposi sarcoma, with or without HIV. NT-I7 strengthens the body's natural defenses to better attack cancer cells.
Eligible Conditions
- Kaposi's Sarcoma
- HIV/AIDS
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants With Adverse Events
Secondary study objectives
Duration of Response (DOR)
Effect of NT-I7 on Kinetics of Absolute Lymphocyte Counts (ALC) in Blood
Effect of NT-I7 on Kinetics of CD4+ T Cells in Blood.
+4 moreOther study objectives
Immunogenicity of NT-I7
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (efineptakin alfa)Experimental Treatment1 Intervention
Patients receive efineptakin alfa IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
147,948 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
570 Previous Clinical Trials
1,340,235 Total Patients Enrolled
Cancer Immunotherapy Trials Network (CITN)UNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a solid organ or stem cell transplant from another person.You are still responding well to antiretroviral therapy for Kaposi's sarcoma.Your platelet count is at least 100,000 per microliter.You are currently being treated for another type of cancer.You currently have tuberculosis.You need to have a recent tumor biopsy, taken within the last 28 days. If that's not possible, a sample taken within the last year can be used.You are able to perform daily activities without help or needing to rest most of the time.You have a low white blood cell count.You need to have a certain number of a type of white blood cell called neutrophils in your blood.If you have HIV, you need to have been taking effective medication for at least 3 months before joining the study, and your Kaposi's sarcoma is still impacting your quality of life.If you have HIV, the amount of the virus in your blood must be very low, as measured by a specific test.If the cancer has spread to your organs, you can still participate if you meet other requirements and have only mild symptoms from the cancer, or if you don't need immediate treatment for it.You have received chemotherapy, radiation therapy, or other treatments for Kaposi's sarcoma within the past 2 weeks before starting the study treatment.You are still dealing with side effects from previous treatment, except for low thyroid levels managed with medicine.You are allergic to products made from Chinese hamster ovary cells or other genetically engineered human antibodies.You have had serious allergic reactions to certain types of medications in the past.You have had an autoimmune disease in the past or are at risk of developing one.You have had a lung condition called idiopathic pulmonary fibrosis or pneumonitis in the past, or your X-ray shows active pneumonitis.You must have a confirmed diagnosis of Kaposi sarcoma through a tissue biopsy.You have a certain type of disease that can be measured using specific guidelines for staging and response assessment.There is no limit on how many treatments you've had before or the stage of your disease.Your hemoglobin level is 9 grams per deciliter or higher.Your total bilirubin level is not too high, unless you have Gilbert's syndrome or are taking HIV protease inhibitors.Your liver function test results must be within a certain range.Your kidney function needs to be good, and your doctor may check it with a urine test.If you have chronic hepatitis B virus (HBV) infection, you must be taking medication to control the virus.You had hepatitis C in the past, but now the virus is not detectable because you received treatment or your body cleared the infection on its own.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (efineptakin alfa)
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.
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