Evaluate the Safety, Immunologic, and Virologic Responses of Donor Derived (DD) HIV-Specific T-ce… (NCT04248192) | Clinical Trial Compass
Active — Not RecruitingPhase 1
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)
United States8 participantsStarted 2020-05-01
Plain-language summary
This is a multi-site phase 1 study of the safety, immunologic and virologic responses of ex vivo expanded donor-derived (DD) HIV-1 multi-antigen specific T-cell (HST) with non-escaped epitope targeting (NEET) therapy as a therapeutic strategy in HIV-infected individuals following Allogeneic Bone Marrow Transplantation (alloBMT).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Participant Inclusion Criteria at Screening:
* Age ≥18 years.
* Confirmation of HIV-1 infection. Any licensed ELISA test kit which is confirmed by Western blot or Multispot HIV-1/HIV-2 assay prior to screening. HIV culture, HIV antigen, plasma HIV RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
* On effective antiretroviral therapy.
* Ability and willingness of participant to continue and be compliant with ART throughout the study.
* Hematologic malignancy that qualifies for standard of care alloBMT according to JHU criteria.
* Potential participant must have adequate organ function for standard of care alloBMT according to JHU criteria.
* No active HCV infection. (If seropositive, participant must have no measureable HCV RNA within 30 days of enrollment).
* No active HBV infection (If seropositive, participant must have no measureable HBV DNA or HBsAg+ within 30 days of enrollment).
* Ability and willingness of participant to give written informed consent.
* Ability and willingness to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the Protocol requirements.
* Ability and willingness to provide adequate locator information and contact information for at least 2 adults who can reach the participant within 24 hours
Participant Inclusion Criteria for DD HST-NEETs Infusion:
* Karnofsky score of ≥ 70.
* ANC ≥ 250/µL.
* Bili…
What they're measuring
1
Any ≥ Grade 3 Adverse Events (as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0)