CD4 CAR+ ZFN-modified T Cells in HIV Therapy

  • STATUS
    Recruiting
  • End date
    Dec 27, 2025
  • participants needed
    12
  • sponsor
    University of Pennsylvania
Updated on 27 January 2021
white blood cell count
HIV Infection
antiretroviral agents
antiretroviral therapy
hiv test
haart
hepatitis
hepatitis b surface antigen
leukapheresis
hiv-1 infection
hiv therapy
hiv-1 rna measurement

Summary

This research study is being carried out to study a new way to possibly treat HIV. As part of this study, doctors will take some of your own white blood cells, called T-cells, and modify them so that they can identify and target your HIV cells. The purpose of the study is to evaluate the safety of these modified T cells and determine whether they have any effect on HIV infection.

Description

Step 1:

Subject is screened, undergoes leukaphereses, and optional rectal biopsy, and safety evaluations before dosing. The University of Pennsylvania manufactures the study product.

Step 2:

Subjects receive a single infusion of 0.5-1x10(10) CD4 CAR+CCR5 ZFN modified T cells. Cohort 2 participants undergo a mini-leukapheresis and optional rectal biopsy at the end of step 2.

The duration of Step 2 will be:

  • Cohort 1: 1 day
  • Cohort 2: 8 weeks

Step 3:

All subjects will participate in a 16 week analytical treatment interruption (ATI). ATI will be less than 16 weeks if patient's viral load is sustained >100,000 or CD4 count <350 or less than 50% of baseline. At the end of step 3 all participants will undergo mini-leukapheresis and optional rectal biopsy.

Step 4:

Participants who have HIV viral loads 1000 copies/ml will continue in an extension of the analytical treatment interruption until viral load is sustained >100,000 or CD4 count <350 or less than 50% of baseline.

Step 5:

Reinitiation of antiretroviral therapy with monthly visits until the HIV RNA is below the limit of quantification. All participants undergo a mini-leukapheresis and optional rectal biopsy at the end of the step 5.

Step 6 (Secondary Follow-up):

All subjects will be followed for safety for up to 5 years post-infusion.

Details
Condition HIV, HIV positive, HIV infection, AIDS Vaccines, HIV (Pediatric), HIV Infections, human immunodeficiency virus, hiv disease, HIV Vaccine, hiv vaccines
Treatment CD4 CAR+CCR5 ZFN T-cells
Clinical Study IdentifierNCT03617198
SponsorUniversity of Pennsylvania
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: HIV infection or AIDS Vaccines or HIV Infections or human immunodeficiency virus or HIV positive or hiv vaccines or hiv disease or HIV or HIV (Pediatr...?
Do you have any of these conditions: human immunodeficiency virus or HIV Vaccine or AIDS Vaccines or HIV Infections or HIV positive or hiv vaccines or HIV or HIV infection or HIV (Pediatr...?
Do you have any of these conditions: HIV or HIV (Pediatric) or HIV Vaccine or hiv disease or HIV infection or hiv vaccines or human immunodeficiency virus or HIV positive or AIDS Vaccines...?
HIV-1 infection
Clinically stable on first or second HAART regimen
Screening CD4+ T cell count of 450 cells/mm3 within 30 days of enrollment; and a documented CD4 nadir of not lower than 200 cells/mm3
Screening HIV-1 RNA that is 50 copies/mL within 30 days prior to enrollment
HIV-1 RNA 50 copies/mL for at least 24 weeks prior to enrollment
Adequate venous access and no other contraindications for leukapheresis
Laboratory values within certain parameters, obtained within 30 days prior to enrollment
Willing to comply with study-mandated evaluations
Male or female, 18 years of age or older
Ability and willingness to provide informed consent
Karnofsky Performance Score of 70 or higher
Negative HBsAg (hepatitis B) within 6 months prior to enrollment
Negative HCV (hepatitis C) serology, or if positive, negative HCV RNA within 6 months prior to enrollment
Have a recorded viral load set point prior to starting antiretroviral therapy

Exclusion Criteria

Acute or chronic hepatitis B or hepatitis C infection
Current or prior AIDS diagnosis
History of cancer or malignancy, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin
History or any features on physical examination indicative of active or unstable cardiac disease or hemodynamic instability (subjects with a history of cardiac disease may participate with a physician's approval)
History or any features of physical examination indicative of bleeding diathesis
Have been previously treated with any HIV experimental vaccine within 6 months prior to screening, or any previous gene therapy using an integrating vector (subjects treated with placebo in an HIV vaccine study will not be excluded if documentation that they received placebo is provided)
Use of chronic systemic corticosteroids, hydroxyurea, or immunomodulating agents within 30 days prior to enrollment (recent or current use of inhaled steroids is not exclusionary)
Breast-feeding, pregnant, or unwilling to use acceptable methods of birth control
Anticipated use of aspirin, dipyridamole, warfarin, or any other medication that is likely to affect platelet function or other aspects of blood coagulation during the 2 week period prior to leukapheresis
Active drug or 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 the study screening visit
Receipt of vaccination within 30 days prior to study screening visit
Have an allergy to hypersensitivity to study product components (human serum albumin, DMSO and Dextran 40)
Currently taking a non-nucleoside reverse transcriptase inhibitor (NNRTI)
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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