Evaluate the Safety, Immunologic, and Virologic Responses of Donor Derived (DD) HIV-Specific T-cells (HST) in HIV-infected Individuals Following Allogeneic Bone Marrow Transplantation (alloRESIST)
|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: NCT04248192|
Recruitment Status : Not yet recruiting
First Posted : January 30, 2020
Last Update Posted : February 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV-Infected Individuals||Biological: DD HST-NEETs||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Safety, Immunologic, and Virologic RESponses of Donor Derived (DD) HIV-Specific T-cells (HST) With Non-escaped Epitope Targeting (NEETs) in HIV-Infected Individuals on Antiretroviral Therapy Following Allogeneic Bone Marrow Transplantation (alloRESIST)|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||April 2024|
Experimental: Donor Derived HIV-Specific T-cells (DD HST-NEETs)
Participants who meet specified inclusion criteria including neutrophil recovery post-transplant and for whom donor products have passed release testing will receive DD HST-NEETs at a dose of 2x107/m2 within 30 days of screening visit.
Biological: DD HST-NEETs
HIV-infected individuals following Allogeneic Bone Marrow Transplantation (alloBMT) will be treated with DD HST-NEETS therapy. Participants and donors will be screened for eligibility. Eligible donors will undergo a blood draw of up to 300mL to allow production of allogeneic DD HST-NEETs. Participants, who meet specified inclusion criteria including neutrophil recovery post-transplant and for whom donor products have passed release testing, will receive DD HST-NEETs at a dose of 2x107/m2 within 30 days of screening visit.
- Any ≥ Grade 3 Adverse Events (as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0) [ Time Frame: 45 days ]Any ≥ Grade 3 Adverse Events will be measured by number of participants who experience Dose Limiting Toxicity which is attributable to the DD HST-NEETS administration.
- The feasibility of manufacturing of DD HST-NEETs [ Time Frame: 3 years ]Feasibility of the manufacturing process will be measured by generation of the cells in 4 or more donors (i.e., a rate of 50% of more).
- The HIV reservoir measurements [ Time Frame: 3 years ]Summarize the HIV reservoir measurements over the pre-BMT, pre-DD HST-NEETs infusion, post-infusion period to assess any change in the HIV reservoir following infusion.
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): NCT04248192
|Contact: Richard Ambinder, MD, PhD||410 firstname.lastname@example.org|
|Principal Investigator:||Richard Ambinder, MD, PhD||Johns Hopkins University|
|Principal Investigator:||Michael Keller, MD||CNMC|