CYT107 for Kaposi's Sarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called CYT107 to determine if it can shrink tumors in people with Kaposi's Sarcoma (KS), a cancer often linked to HIV. CYT107 is a lab-made protein designed to boost the immune system by increasing T cells. The trial seeks participants with HIV-associated KS who have at least five measurable skin lesions and experience a persistent impact on their quality of life despite effective HIV treatment. Participants will receive CYT107 injections for up to four weeks, with the possibility of additional treatment if improvements occur. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you must not have received chemotherapy, radiotherapy, or other KS-directed therapy within 2 weeks before starting the study drug. Also, you should not have taken systemic immunosuppressive or immunostimulatory agents within 2 weeks before starting the trial.
Is there any evidence suggesting that CYT107 is likely to be safe for humans?
Research has shown that CYT107, a lab-made human protein, has been tested in people to assess its safety. In earlier studies, CYT107 was generally well-tolerated, with most side effects being mild to moderate, such as mild pain at the injection site and a low-grade fever. No serious side effects were consistently linked to the treatment.
The treatment is now in a Phase 2 trial, indicating it has already demonstrated some safety in earlier studies. Phase 2 trials focus more on the treatment's effectiveness while still monitoring safety. This stage involves more participants, helping researchers better understand any side effects.
CYT107 is also under investigation for other conditions, suggesting researchers have confidence in its safety. However, it is important to remember that all treatments can have risks, so discussing these with a healthcare provider is always advisable.12345Why do researchers think this study treatment might be promising?
Researchers are excited about CYT107 for Kaposi's Sarcoma because it offers a novel approach by boosting the immune system. Unlike current treatments, which often involve chemotherapy or antiretroviral therapy targeting the virus causing the condition, CYT107 focuses on strengthening the body's immune response. This could potentially lead to more effective control of the disease with fewer side effects, offering hope for improved outcomes in patients with Kaposi's Sarcoma.
What evidence suggests that CYT107 might be an effective treatment for Kaposi's Sarcoma?
Research has shown that CYT107, the treatment under study in this trial, might help treat Kaposi's sarcoma (KS) by strengthening the immune system. This treatment aims to increase T cells, which are key immune cells. Studies have found that boosting these cells can aid people with HIV-related KS, as their immune systems are often weaker. Some early results suggest that CYT107 can shrink KS tumors by enhancing the body's natural defenses. While more data is needed, this approach seems promising for those with HIV-related KS.15678
Who Is on the Research Team?
Ramya M Ramaswami, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
This trial is for adults over 18 with HIV-associated Kaposi Sarcoma (KS). They must have at least five measurable skin lesions not previously treated with radiation or surgery, and their symptoms should be mild. Participants need to have been on effective anti-HIV therapy for two months, with a viral load of less than or equal to 100 copies/mL.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CYT107 injections once a week for up to 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Optional Second Treatment Course
Participants who show improvement may receive a second 4-week course of CYT107 within a year
What Are the Treatments Tested in This Trial?
Interventions
- CYT107
Trial Overview
The trial tests CYT107, a lab-made protein that may boost immunity by increasing T cells in people with HIV-related KS. It involves weekly injections into the muscle for up to four weeks, which can be repeated after improvement. The study includes physical exams, blood tests, lung x-rays, and lesion measurements over three years.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Treatment with CYT107
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
Recombinant Glycosylated Human Interleukin-7 (CYT107 ...
Background: Kaposi sarcoma (KS) is a cancer that causes abnormal tissue to grow in the skin, lymph nodes, and other organs.
Phase I study of efineptakin alfa (NT-I7) for the treatment of ...
AMC-070: Lenalidomide Is Safe and Effective in HIV-Associated Kaposi Sarcoma. Clin Cancer Res. 2022;28:2646–56. doi: 10.1158/1078-0432.CCR ...
🧬🏛️ The Immune Non-Responder State #RevImmune IL-7 ...
Checkpoint inhibitors have demonstrated limited efficacy in Kaposi sarcoma, and current clinical guidelines list them cautiously in relapsed ...
4.
clinicaltrials.gov
clinicaltrials.gov/study/NCT01190111?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(nih%20400))&rank=4Study on Interleukin-7 (CYT107) in HIV Patients
This study was designed to evaluate the pharmacokinetics of 20µg/kg/week of Interleukin-7 (CYT107), the biological activity and safety of repeated cycles of ...
5.
researchgate.net
researchgate.net/publication/388772328_Phase_I_study_of_efineptakin_alfa_NT-I7_for_the_treatment_of_Kaposi_sarcoma(PDF) Phase I study of efineptakin alfa (NT-I7) for the ...
Purpose VEGF-A is important in the pathogenesis of Kaposi sarcoma, and bevacizumab has a response rate of 31%. We explored the combination of bevacizumab with ...
6.
clinicalstudies.info.nih.gov
clinicalstudies.info.nih.gov/htmlSearchedFile.aspx?Query=Rectum%20Sarcoma&status=&gender=Select%20One&Inst=&age=&healthyVolunteer=0NIH Clinical Center: Search the Studies
Phase II Study of Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants with HIV and Immune Non-response ( ...
Phase I study of efineptakin alfa (NT-I7) for the treatment ...
We hypothesize that IL-7 treatment may be beneficial in Kaposi sarcoma (KS), where CD4+ T cell lymphopenia is associated with KS onset. There ...
Interleukin-7 (CYT107) Treatment of Idiopathic CD4 ...
SAMPLE SIZE - Approximately 35-40 patients will be screened over a 3-year period to achieve the desired sample of 18 ICL patients, allowing for a primary safety ...
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