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NT-I7 for Kaposi Sarcoma
Study Summary
This trial is testing a new medication, NT-I7, to see if it can help treat Kaposi sarcoma. NT-I7 works by using a patient's immune system to fight cancer.
- Kaposi's Sarcoma
- HIV/AIDS
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Treatment (efineptakin alfa)
- 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
What is the scope of this trial and which hospitals are participating?
"The research is taking place in the Fred Hutch/University of Washington Cancer Consortium, Zuckerberg San Francisco General Hospital, and National Institutes of Health Clinical Center, all located within Seattle, California and Maryland respectively. In addition to these three main sites there are five additional clinical trial centres participating in this project."
Is there a body of research relating to Efineptakin alfa?
"Efineptakin alfa's first clinical trial was conducted at UCSF Comprehensive Cancer Center in 2018, yet no studies have been finalized. Currently 11 active trials are being administered with the majority situated near Seattle, Washington."
How many participants can this research endeavor accommodate?
"This medical trial requires 20 qualified participants. Potential enrollees can come from a range of different sites, such as Fred Hutch/University of Washington Cancer Consortium in Seattle and Zuckerberg San Francisco General Hospital in California."
Has this experimentation been attempted before?
"Currently, 11 separate studies for Efineptakin alfa are being conducted in 39 urban areas and 4 countries. The initial trial of this drug by NeoImmuneTech began back in 2018 with 12 participants and achieved Phase 1 approval. Since then, 0 clinical trials have been closed out."
Are new participants still able to enroll in this experiment?
"That is correct. According to clinicaltrials.gov, the recruitment of participants for this medical study has been in progress since May 23rd 2022 and was recently revised on October 21st 2022. Altogether, 20 patients are needed at 5 different sites involved in the trial."
Has Efineptakin alfa received clearance from the US Food and Drug Administration?
"Taking into account the limited data surrounding Efineptakin alfa, our team has classified its safety as a 1 on a scale of 1 to 3."
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