RECRUITING

CAR-T Cells for HIV Infection

Conditions

HIV Infections HIV HIV/AIDS CAR-T cells HIV cure HIV reservoir Immunotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a limited-center, open-label dose escalating phase I/IIa study of autologous T cells expressing LVgp120duoCAR molecules in people with HIV infection. It will follow a 3+3 design. Dose escalation decisions will be made when a minimum of three participants have completed the safety-evaluation period (45 days) at a given dose level. Cohort 1 will undergo infusion of a single low-dose regimen of LVgp120duoCAR-T cells. Cohort 2 will undergo non-ablative conditioning with cyclophosphamide, followed by infusion of a single low-dose regimen of LVgp120duoCAR-T cells. Cohort 3 will undergo non-ablative conditioning with cyclophosphamide, followed infusion of a single high-dose regimen of LVgp120duoCAR-T cells. Following administration of the experimental therapy, HIV medications will be paused for participants in each group during an analytic treatment interruption.

Official Title

Safety and Anti-HIV Activity of Autologous CD4+ and CD8+ T Cells Transduced With a Lentiviral Vector Encoding Bi-specific Anti-gp120 CAR Molecules (LVgp120duoCAR-T) in Anti-retroviral Drug-treated HIV-1 Infection

Quick Facts

Study Start:2021-03-01

Study Completion:2028-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04648046

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male or female, age ≥ 18 and ≤ 65 years * HIV-1 infection * On continuous antiretroviral therapy for at least 12 months without any interruptions of greater than 14 consecutive days, and on a stable regimen that does not include a non-nucleoside reverse transcriptase inhibitor (NNRTI) for at least 4 weeks or any long-acting ART drug that may be active in the participant after ART interruption for up to one year, without plans to modify ART during the study period * Screening plasma HIV RNA levels below the limit of quantification on all available determinations in past 12 months (isolated single values ≥ 40 but \< 200 copies/mL will be allowed if they were preceded and followed by undetectable viral load determinations) * CD4+ T cell count nadir \> 300 cells/mm3 * Screening CD4+ T-cell count ≥ 500 cells/mm3 * Available ART treatment history and the capacity to construct an effective antiretroviral treatment regimen * Willing to pause ART as part of the study	* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study * ART regimen that includes a long-acting anti-HIV drug and/or NNRTI that may be active in the participant for up to one year after ART interruption * ART regimen that includes protease inhibitor(s) and/or AZT. These drugs may increase the toxicity of cyclophosphamide. * Any history of an HIV-associated malignancy, including Kaposi's sarcoma and any type of lymphoma, or virus-associated cancers * History of or current active hepatitis B (HBV) infection defined as positive HBV surface antigen test. A positive anti-HBc regardless of HBsAg status. * Active hepatitis C (HCV) infection * Active or latent tuberculosis infection * Chronic liver disease * Active and poorly controlled atherosclerotic cardiovascular disease * Unwillingness to abstain from sex or use barrier protection for any sexual activity during the treatment interruption.

Inclusion Criteria

Exclusion Criteria

* Male or female, age ≥ 18 and ≤ 65 years
* HIV-1 infection
* On continuous antiretroviral therapy for at least 12 months without any interruptions of greater than 14 consecutive days, and on a stable regimen that does not include a non-nucleoside reverse transcriptase inhibitor (NNRTI) for at least 4 weeks or any long-acting ART drug that may be active in the participant after ART interruption for up to one year, without plans to modify ART during the study period
* Screening plasma HIV RNA levels below the limit of quantification on all available determinations in past 12 months (isolated single values ≥ 40 but \< 200 copies/mL will be allowed if they were preceded and followed by undetectable viral load determinations)
* CD4+ T cell count nadir \> 300 cells/mm3
* Screening CD4+ T-cell count ≥ 500 cells/mm3
* Available ART treatment history and the capacity to construct an effective antiretroviral treatment regimen
* Willing to pause ART as part of the study

* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
* ART regimen that includes a long-acting anti-HIV drug and/or NNRTI that may be active in the participant for up to one year after ART interruption
* ART regimen that includes protease inhibitor(s) and/or AZT. These drugs may increase the toxicity of cyclophosphamide.
* Any history of an HIV-associated malignancy, including Kaposi's sarcoma and any type of lymphoma, or virus-associated cancers
* History of or current active hepatitis B (HBV) infection defined as positive HBV surface antigen test. A positive anti-HBc regardless of HBsAg status.
* Active hepatitis C (HCV) infection
* Active or latent tuberculosis infection
* Chronic liver disease
* Active and poorly controlled atherosclerotic cardiovascular disease
* Unwillingness to abstain from sex or use barrier protection for any sexual activity during the treatment interruption.

Contacts and Locations

Study Contact

Rebecca Hoh

CONTACT

415-476-4082

rebecca.hoh@ucsf.edu

Principal Investigator

Steven Deeks, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, Davis

Sacramento, California, 95817

United States

Zuckerberg San Francisco General

San Francisco, California, 94110

United States

Collaborators and Investigators

Sponsor: Steven Deeks

Steven Deeks, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-01

Study Completion Date2028-12-31

Study Record Updates

Study Start Date2021-03-01

Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

HIV
HIV/AIDS
CAR-T cells
HIV cure
HIV reservoir
Immunotherapy

Additional Relevant MeSH Terms

HIV Infections