HIV-Infected IndividualsPhase 1NCT04248192
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)
A Phase 1 study testing DD HST-NEETs in people with HIV-Infected Individuals, run by Catherine Bollard at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-Infected Individuals
- What is being tested?
- DD HST-NEETs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Bilirubin ≤ 2x upper limit normal or direct bilirubin normal.
- AST ≤ 3x upper limit normal.
- Serum creatinine ≤ 2x upper limit normal.
- Hgb ≥ 7.0 g/dL.
- Pulse oximetry of > 90% on room air.
- Negative pregnancy test in female participants if applicable (childbearing potential).
- Written informed consent signed by participant or guardian.
- Steroids less or equal to 0.5 mg/kg/day prednisone.
- Donor Inclusion Criteria for Procurement for DD HST-NEETS Manufacturing:
- Donors for allogeneic (i.e. HLA matched or mismatched related or unrelated) hematopoietic cell transplants who have fulfilled eligibility for and consented to stem cell donation as per JHU standard operating procedures.
- Donor must be in good health based on institutional guidelines.
- Female donors of childbearing age must have a negative pregnancy test and must not be lactating.
- It is understood that medical clearance from the donor will be sought within the timeline per the National Marrow Donor Program (NMDP) rules.
- The hematopoietic cell donor will have already been selected by the JHU BMT Donor Selection Committee.
- Donor or parent/guardian capable of providing informed consent
Who cannot join
- Participant Exclusion Criteria DD HST-NEETs Infusion:
- Participants receiving ATG, or Campath or other immunosuppressive T-cell monoclonal antibodies within 28 days.
- Participants with uncontrolled infections. For bacterial infections, participants must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections participants must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection.
- Participants who have received donor lymphocyte infusion (DLI) within 28 days.
- Active and uncontrolled relapse of malignancy.
- Participants with active acute GVHD grades II-IV
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- Participants with bronchiolitis obliterans syndrome or serositis
- Any licensed or experimental non-HIV vaccination (e.g., hepatitis B, pneumococcal polysaccharide) within 28 days prior to study entry.
- Inability to comply with study requirements, which could impact study integrity and/or safety.
- Donor Exclusion Criteria for Procurement for DD HST-NEETs Manufacturing:
- Donor exclusion criteria will be followed as per institution standard operating procedures (SOPs).
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University(Jhu)
Baltimore, Maryland, 21231
About this study
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)
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).
Read the detailed description
The primary objective of this study is to evaluate the safety of donor-derived allogeneic expanded HIV-specific T-cell therapy (DD HST-NEETs) in HIV-infected alloBMT recipients on ART. 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.
- Conditions
- HIV-Infected Individuals
- Being tested
- DD HST-NEETs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DD HST-NEETsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Donor Derived HIV-Specific T-cells (DD HST-NEETs) | Experimental | 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. Receives: Biological: DD HST-NEETs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any ≥ Grade 3 Adverse Events (as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0)
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.
Measured: 45 days
Secondary outcomes (2)
The feasibility of manufacturing of DD HST-NEETs
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).
Measured: 3 years
The HIV reservoir measurements
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start1 May 2020
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-Infected IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catherine Bollard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Catherine Bollard, Children's National Research Institute
- Investigators
- Richard Ambinder, MD, PhD, Principal investigator, Johns Hopkins UniversityMichael Keller, MD, Principal investigator, CNMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248192
- Sponsor's protocol ID
- Pro00012451
- Status last verified
- Aug 2026
- First submitted
- 28 Jan 2020
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04248192
- Acronym / sponsor ID
- Pro00012451
- Conditions
- HIV-Infected Individuals
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Catherine BollardUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The primary objective of this study is to evaluate the safety of donor-derived allogeneic expanded HIV-specific T-cell therapy (DD HST-NEETs) in HIV-infected alloBMT recipients on ART. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Donor Derived HIV-Specific T-cells (DD HST-NEETs) | Experimental | Biological: DD HST-NEETsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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.
Key exclusion criteria (11 listed)
- Participants receiving ATG, or Campath or other immunosuppressive T-cell monoclonal antibodies within 28 days.
- Participants with uncontrolled infections. For bacterial infections, participants must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections participants must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection.
- Participants who have received donor lymphocyte infusion (DLI) within 28 days.
- Active and uncontrolled relapse of malignancy.
- Participants with active acute GVHD grades II-IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DD HST-NEETsHIV-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. | Biological | Donor Derived HIV-Specific T-cells (DD HST-NEETs) |
Primary outcome
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.
2 secondary outcomes
The feasibility of manufacturing of DD HST-NEETs
Time frame: 3 years
The HIV reservoir measurements
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Ambinder, MD, PhD principal investigator
Johns Hopkins University
Michael Keller, MD principal investigator
CNMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DD HST-NEETs in people with HIV-Infected Individuals, run by Catherine Bollard at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.