NT-I7 for Kaposi Sarcoma in Patients With or Without HIV
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04893018|
Recruitment Status : Not yet recruiting
First Posted : May 19, 2021
Last Update Posted : September 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|AIDS-Related Kaposi Sarcoma HIV Infection Kaposi Sarcoma||Biological: Efineptakin alfa||Phase 1|
OUTLINE: This is a dose-escalation study.
Patients receive efineptakin alfa intramuscularly (IM) on day 1. Cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up on day 7 and then every 12 weeks for 15 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of NT-I7 (rhIL-7-hyFc) for the Treatment of Kaposi Sarcoma in Patients With or Without Infection With HIV|
|Estimated Study Start Date :||October 2, 2021|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||June 30, 2025|
Experimental: Treatment (efineptakin alfa)
Patients receive efineptakin alfa IM on day 1. Cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Biological: Efineptakin alfa
- Incidence of adverse events [ Time Frame: Up to 30 days after last dose of NT-I7 ]Measured by Common Terminology Criteria for Adverse Events version 5.0.
- Objective response rate (ORR) [ Time Frame: 12 months ]Will be assessed according to modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group Criteria (ACTG) criteria.
- Duration of response (DOR) [ Time Frame: Up to 1 year ]Will be measured in subjects who obtain a partial response or better and defined as time from the best response within the first 48 weeks of therapy until disease progression or censoring. Kaplan Meier survival estimates will be constructed for each of these survival endpoints with 95% confidence intervals (CIs), for up to 1 year following initiation of treatment in all participants.
- Progression-free survival (PFS) [ Time Frame: From the time from administration of the first dose of NT-I7 until disease progression or death or censoring, assessed up to 1 year ]Kaplan Meier survival estimates will be constructed for each of these survival endpoints with 95% CIs, for up to 1 year following initiation of treatment in all participants.
- Overall survival (OS) [ Time Frame: From administration of the first dose of NT-I7 until death or censoring, assessed up to 1 year ]Kaplan Meier survival estimates will be constructed for each of these survival endpoints with 95% CIs, for up to 1 year following initiation of treatment in all participants.
- Kinetics of CD4+ and CD8+ T cells in blood, and on levels and phenotype within tumors [ Time Frame: Up to 15 months after last dose of NT-I7 ]
- Immunogenicity of NT-I7 [ Time Frame: Up to 15 months after last dose of NT-I7 ]The proportion of participants developing neutralizing antibodies will be summarized.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04893018
|Contact: CITN Central Operations and Statistical Center Coordinatoremail@example.com|
|United States, California|
|Zuckerberg San Francisco General Hospital|
|San Francisco, California, United States, 94110|
|Contact: Chia-Ching (Jackie) Wang 415-476-4082 Paul.Couey@ucsf.edu|
|Principal Investigator: Chia-Ching (Jackie) Wang|
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Contact: Irene Ekwede, R.N. 240-760-6126 firstname.lastname@example.org|
|Principal Investigator: Ramya Ramaswami|
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Contact: Philip Friedlander, MD, PhD 212-824-8588 email@example.com|
|Principal Investigator: Philip Friedlander, MD, PhD|
|United States, Washington|
|Harborview Medical Center|
|Seattle, Washington, United States, 98104|
|Contact: Alison Kunze 206-744-5828 firstname.lastname@example.org|
|Principal Investigator: Manoj Menon|
|Principal Investigator:||Chia-Ching (Jackie) Wang||University of California, San Francisco|