HIV-1 Specific T -Cells (HST-NEETs) for HIV-Infected Individuals (RESIST)
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|ClinicalTrials.gov Identifier: NCT03485963|
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : July 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Biological: HST-NEETs||Phase 1|
Treatment Description: This is a phase I, multi-site, study of the safety, immunologic and virologic responses of ex vivo expanded HIV-1 multi-antigen specific T-cell therapy (HST-NEET) as a therapeutic strategy in HIV-infected individuals suppressed on ART. Patients will be screened for eligibility in Step 1 and undergo a blood draw of 100-120mL to allow production of autologous HST-NEETS. Those meeting study eligibility and with successful production of HST-NEETs will then enter Step 2 where patients have the OPTION of being enrolled on a separate GWU Protocol 04216 to obtain a pre- and post- HST-NEET treatment leukapheresis procedure to measure the frequency of HIV-1 infection of resting CD4+ T cells using the viral outgrowth assay. All participants will then receive (within 30 days of the leukapheresis procedure if applicable) the same treatment and dose (2x107/m2) of HST-NEETs in Step 2. For the first 3 recipients, the infusions will occur 4 weeks apart. If no adverse reactions occur that are attributable to the HST-NEETs, the recipients thereafter will receive the two infusions separated by 2 weeks.
Sample Size and Study Duration: Up to 12 HIV-infected individuals followed for 48 weeks.
Accrual Objective: The total sample size is 12 participants. Participants will be followed for 48 weeks. Because the focus of the study is on safety and potential adverse events are most likely to occur within 28 days of administration, accrual will be staggered such that enrollment and treatment administration will include a maximum of 1 participant per week. Participants who do not receive study treatment will be replaced. In addition, any participant who is not administered the full study treatment infusion, or discontinues the study prior to day 28 without having met the primary safety endpoint will be replaced until the target enrollment of participants is met.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study to Evaluate the Safety, Immunologic, and Virologic RESponses of HIV-Specific T-cells With Non-escaped Epitope Targeting (HST-NEETs) as a Therapeutic Strategy in HIV-Infected Individuals on Antiretroviral Therapy During Acute And Chronic Infection|
|Actual Study Start Date :||March 21, 2019|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Fixed dose HIV-1 specific T-cells (HST-NEETs)
Patients will be screened for eligibility in Step 1 and undergo a blood draw of 100-120mL to allow production of autologous HST-NEETS. patients will receive a fixed dose of 2x10e7/m2. For the first 3 recipients, the infusions will occur 4 weeks apart. If no adverse reactions occur that are attributable to the HST-NEETs, the recipients thereafter will receive the two infusions separated by 2 weeks.
The primary objective of this study is to evaluate the safety and tolerability of expanded HIV-specific T cell therapy (HST-NEETs) in HIV-infected individuals suppressed on cART. Patients with a partial response or stable disease 8 weeks after T-cell infusion were eligible to receive additional T-cells, consisting of the same number of cells as their second injection.
- Incidence of Product-Emergent Adverse Events [ Time Frame: from the first day of study treatment until 28 days after the last infusion. ]Occurrence of any ≥ Grade 3 AE including signs/symptoms, lab toxicities, and/or clinical events, that is possibly, probably or definitely related to study treatment any time from the first day of study treatment until 28 days after the last infusion. Safety data will include local and systemic signs and symptoms, laboratory measures of safety/toxicity, and all adverse and serious adverse events. Safety data will be routinely collected throughout the duration of the study. Relationship to study treatment will be judged by the protocol team. If any Grade 4 or 5 Serious Adverse Events occur, this will trigger an immediate pause in the protocol while the relationship to the T cell therapeutic is evaluated. If the attribution is deemed probably or definitely related to the study agent, the protocol will stop.
- HST-NEETS responses [ Time Frame: 12 months ]Determine the number of patients who respond to HST_NEETS
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): NCT03485963
|Contact: Michael Keller, MD||202-476-5843||MKeller@childrensnational.org|
|Contact: Fahmida Hoq, MBBS, MSfirstname.lastname@example.org|
|United States, District of Columbia|
|Whitman Walker Health Research Department (Wwh)||Recruiting|
|Washington, District of Columbia, United States, 20005|
|Contact: Deborah Goldstein, MD email@example.com|
|Contact: Lynsay MacLaren, PA-C, MPH, MPAS LMacLaren@whitman-walker.org|
|Principal Investigator: Deborah Goldstein, MD|
|Principal Investigator: Sarah Henn, MD|
|Sub-Investigator: Lynsay MacLaren MacLaren, PA-C, MPH, MPAS|
|Children's National Health System||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Fahmida Hoq, MBBS, MS 202-476-3634 firstname.lastname@example.org|
|Children's National Medical Center, GEORGE WASHINGTON UNIVERSITY HOSPITAL andWHITMAN WALKER HEALTH RESEARCH DEPARTMENT (WWH)||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Fahmida Hoq 202-476-3634 email@example.com|
|Principal Investigator:||Michael Keller, MD||CNMC|