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CAR T-cell Therapy
Modified T Cells for HIV Therapy
Phase 1
Waitlist Available
Led By Pablo Tebas, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HIV-1 infection
Karnofsky Performance Score of 70 or higher
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 1 year.
Awards & highlights
Study Summary
This trial is testing a new way to treat HIV by taking the patient's white blood cells, modifying them to target HIV cells, and seeing if it's safe and effective.
Who is the study for?
This trial is for adults over 18 with HIV who've had a stable viral load (≤50 copies/mL) for at least 24 weeks, are on their first or second antiretroviral therapy, and have certain levels of T cells. They must not have hepatitis B/C, AIDS, cancer history (except some skin cancers), heart disease without approval, bleeding disorders, recent gene therapy or experimental vaccines for HIV.Check my eligibility
What is being tested?
The study tests modified T-cells designed to fight HIV. Participants' own T-cells will be taken and genetically altered using CD4 CAR+CCR5 ZFN technology to target the virus. The goal is to assess safety and impact on the infection.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune response such as inflammation or discomfort at injection sites. There could also be risks associated with genetic modification but these are currently unknown due to the novel nature of this treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am infected with HIV-1.
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I am mostly able to care for myself.
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I can undergo leukapheresis without any health issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of subjects with treatment related adverse events.
Secondary outcome measures
Compare the change in CD4 count.
Compare the percentage of enriched modified CD4 CAR+ CCR5 ZFN cells and their subsets.
Compare viral set point log 10 HIV RNA level.
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
Cohort 2 subjects will begin treatment interruption approximately 8 weeks after they receive the modified T-cells. All other study procedures are the same as Cohort 1.
Group II: Cohort 1Experimental Treatment1 Intervention
Cohort 1 subjects will begin treatment interruption approximately 24 hours after they receive the modified T-cells. All other study procedures are the same as Cohort 2.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,076 Total Patients Enrolled
Pablo Tebas, MDPrincipal InvestigatorUniversity of Pennsylvania
18 Previous Clinical Trials
578 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am infected with HIV-1.I have a condition that causes unusual bleeding.I don't have active or unstable heart problems, or if I do, my doctor approves my participation.I am stable on my first or second HIV treatment plan.I plan to use medications like aspirin that might affect blood clotting before a special blood collection procedure.I haven't been hospitalized or needed treatment for a serious illness in the last 30 days.I have been diagnosed with AIDS.I have hepatitis B or C.I have had cancer before, but it was not skin cancer or it was successfully treated skin cancer.I have not received any HIV experimental vaccine or gene therapy in the last 6 months.I haven't taken steroids, hydroxyurea, or immune system drugs in the last 30 days.I am mostly able to care for myself.I am currently on NNRTI medication.I can undergo leukapheresis without any health issues.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2
- Group 2: Cohort 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned CD4 CAR+CCR5 ZFN T-cells for medical use?
"Due to the limited amount of research conducted on CD4 CAR+CCR5 ZFN T-cells, our team at Power has assigned it a safety score of 1. This is because this is only in the first phase of clinical trials and there are scant data points supporting both efficacy and safety."
Answered by AI
Are participants being accepted for the current clinical trial?
"Per clinicaltrials.gov, this specific trial is not currently enrolling participants; the post was first published on July 31st 2019 and last updated October 11th 2022. In contrast, 83 other trials are presently seeking patients for their research studies."
Answered by AI
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