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HIVPhase 1NCT04561258

Study to Evaluate the Safety of a Gene and Cell Therapy Product in Participants With HIV That is Well-Controlled on Antiretroviral Therapy

A Phase 1 study testing AGT103-T in people with HIV, run by American Gene Technologies International Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1 study to assess the safety of a gene and cell therapy for autologous donor lymphocyte infusion in HIV+ participants with well-controlled viremia on antiretroviral therapy. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
HIV
What is being tested?
AGT103-T
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
2 sitesUnited States
Study dates
12 Oct 2020to 21 Nov 2022
Phase
Phase 1
Are there results?
None posted in the registry

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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male or female between 18-60 years
  • Documented HIV infection for ≥3 years
  • Suppression of HIV to <50 copies of viral RNA/mL plasma for ≥2 years. Participants who had intermittent, isolated episodes of detectable low-level viremia (<500c/mL; blips) will remain eligible. Participant must have a complete antiretroviral treatment history including past and present data on resistance to antiretroviral therapy
  • Agree to continue their current antiretroviral regimen during the study period unless change in treatment with antiretroviral regimen is medically indicated
  • Have, in the Investigator's opinion, a fully active alternative antiretroviral regimen that can be used if resistance develops to the current antiretroviral therapy regimen
  • CD4 T cell count >400 cells/mm3
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  • Has adequate organ function as indicated by the following laboratory values:
  • Hematocrit ≥33% or hemoglobin ≥13g/dL (males) and ≥12g/dL (females)
  • Platelet count ≥150,000/mm3
  • Absolute neutrophil count ≥1,500/mm3
  • Serum creatinine ≤1.3 times ULN or calculated creatinine clearance (for those with creatinine >1.3 ULN) ≥60mL/min
  • Prothrombin Time or INR ≤ 1.5 times ULN
  • Total bilirubin <1.5 times the ULN range. If total bilirubin is elevated, direct bilirubin must be < 2 times the ULN range, except in participants with Gilbert's Syndrome who must have serum bilirubin <3.0 times ULN (NOTE: If participant is on an atazanavir containing therapy then a direct bilirubin should be measured instead of the total bilirubin and must be ≤ 1.0mg/dL. Also, asymptomatic elevations due to ART medications are not exclusionary when, in the opinion of the Investigator, the abnormalities are not attributable to intrinsic hepatic disease).
  • Amylase < 3 times ULN at the time of screening
  • AST (SGOT) and ALT (SGPT): ≤ 3.0 times ULN
  • Adequate venous access, per Investigator judgement, and no other contraindications for leukapheresis
  • Weight (without shoes) ≥50 kilograms
  • Has the ability to understand the study and must be willing to comply with study-required procedures and visits
  • Written informed consent signed and dated by the study participant
  • A negative pregnancy test for females of childbearing potential. A female participant is considered to be of childbearing potential if she is menstruating, has an intact uterus and at least 1 ovary, and is less than 2 years postmenopausal.
  • Unless medically prescribed, a negative drug test for amphetamines; barbiturates; benzodiazepines; cocaine; methadone (Dolophine®); opiates (codeine, morphine only); phencyclidine (PCP); propoxyphene
  • Agree to participate in the 15-year Long-Term Follow-Up study

Who cannot join

  • Active viral hepatitis B or hepatitis C infection. A complete hepatitis B virus (HBV) screen (B-core antibody, HBV surface antibody, and HBV surface antigen testing) must be completed. Viral load testing will be used in questionable cases, per the discretion of the Investigator.
  • The results for hepatitis B may be positive for surface antibodies against HBV but must be negative for circulating HBV surface antigen to confirm the absence of active infection and negative for HBV core antigen to excluded previous active hepatitis
  • The results for hepatitis C virus (HCV) may be positive for antibodies against HCV but must be negative for HCV viral RNA in blood to confirm the absence of active infection.
  • Liver disease by any cause
  • Active or history (within 5 years prior to screening) of at least one acquired immune deficiency syndrome (AIDS)-defining complication
  • CD4 T cell nadir of <200 cells/mm3, if the information is available at the time of screening per medical records. If this information is unavailable, the Investigator will document this in the study source records
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  • Cancer or malignancy that has not been in remission for at least 5 years prior to screening, with the exception of successfully treated basal cell carcinoma of the skin
  • Current diagnosis of congestive heart failure, uncontrolled angina, or arrhythmias
  • Baseline prolonged QTc (Fridericia Formula) of 450 ms or more
  • Any clinically significant renal, hepatic, or pulmonary disease
  • History of active or latent tuberculosis, regardless of treatment history
  • Asplenia
  • Received high dose cytoreduction therapy within 3 months prior to screening
  • Currently taking (or has taken within 6 months prior to screening) the antiretroviral drug Selzentry (Maraviroc)
  • Currently using protease inhibitors, efavirenz, or zidovudine
  • Prior events of hemorrhagic cystitis
  • Evidence of urinary outflow obstruction by history, enlarged prostate on physical exam, or use of medications for urinary outflow obstruction
  • Is being treated for culture-confirmed bacteremia or had culture-confirmed bacteremia within 1 month prior to screening
  • Has signs or symptoms of acute infectious disease
  • History of hereditary angioedema, acquired angioedema, or idiopathic angioedema
  • History of neurological diseases
  • Significant laboratory values and/or chronic medical condition that in the opinion of the Investigator could impact trial participation
  • Received another investigational drug or device within 30 days of screening
  • Previously received any gene transfer therapy
  • History or any features on physical examination indicative of a bleeding diathesis
  • Use of aspirin, dipyridamole, warfarin and antithrombin inhibitors or any other medication that is likely to affect platelet function or other aspects of blood coagulation within 3 days prior to the Leukapheresis Visit
  • Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents (e.g., monoclonal antibodies, interleukin-2, interferon-alpha or gamma, granulocyte colony stimulating factors, etc.) within 30 days prior to screening (NOTE: Use of inhaled or topical steroids is not exclusionary)
  • Currently pregnant or breast-feeding
  • Unwilling to use acceptable methods of birth control for 6 months following the infusion of AGT103-T if sexually active with opposite sex. The following are acceptable methods of birth control: condoms (male or female) with or without a spermicidal agent, intrauterine device, diaphragm or cervical cap with spermicide, or hormonal-based contraception
  • Active alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirements
  • Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to screening
  • Recent vaccination or intercurrent illness within 5 weeks prior to screening (NOTE: It is recommended that participants should have completed their routine vaccinations, e.g., hepatitis A or B, pneumococcus, influenza and tetanus diphtheria booster, at least 5 weeks prior to screening for the study)
  • Known allergy to Dimethyl Sulfoxide (DMSO)
  • Known allergy to Cyclophosphamide

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Georgetown University

    Washington D.C., District of Columbia, 20007

  • Washington Health Institute

    Washington D.C., District of Columbia, 20017

Other trials in United States

About this study

Official title: Phase 1 Study to Evaluate the Safety of Genetically Modified, Autologous T Cells in Participants With HIV That is Well-Controlled on Antiretroviral Therapy

This is a Phase 1 study to assess the safety of a gene and cell therapy for autologous donor lymphocyte infusion in HIV+ participants with well-controlled viremia on antiretroviral therapy.

Conditions
HIV
Being tested
AGT103-T

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AGT103-TBiological

    An autologous, genetically modified PBMC product enriched with HIV-specific and resistant CD4 T cells

Study groups in NCT04561258
Study groupRoleWhat they receive
Low Dose CohortExperimentalA single infusion of ≥1x10e8 and <1x10e9 genetically modified T cells.
Receives: Biological: AGT103-T
High Dose CohortExperimentalA single infusion of ≥1x10e9 and <5x10e9 genetically modified T cells.
Receives: Biological: AGT103-T

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess the safety of AGT103-T in HIV+ participants with well-controlled viremia on antiretroviral therapy: adverse events

    Incidence of adverse events related to AGT103-T will be graded using NCI CTCAE (v5.0)

    Measured: Days 1 to 180 post-infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2020
  2. Study start12 Oct 2020
  3. Primary completion15 Aug 2022
  4. Study completion21 Nov 2022

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04561258
Sponsor's protocol ID
AGT-HC168
Status last verified
Apr 2023
First submitted
14 Sep 2020
Last updated
12 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Jain A, Liou ML, Xiao L, Canepa GE. Impact of AGT103-T cell and gene therapy on intact HIV proviral reservoirs. AIDS. 2026 Jul 1;40(7):880-884. doi: 10.1097/QAD.0000000000004459. Epub 2026 Feb 11.

    PubMed 41670418

  • Pauza CD, Huang K, Bordon J. Advances in cell and gene therapy for HIV disease: it is good to be specific. Curr Opin HIV AIDS. 2021 Mar 1;16(2):83-87. doi: 10.1097/COH.0000000000000666.

    PubMed 33625039

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AGT103-T in people with HIV, run by American Gene Technologies International Inc. at 2 sites 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 22 inclusion and 34 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: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Assess the safety of AGT103-T in HIV+ participants with well-controlled viremia on antiretroviral therapy: adverse events (time frame: Days 1 to 180 post-infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04561258, which also lists 2 linked publications.

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 12 Apr 2023.

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