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CAR T-cell Therapy
CAR T Cells for HIV
Phase < 1
Recruiting
Led By John H. Baird, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be ≥ 18 years of age at the time of screening
Karnofsky Performance Status (KPS) ≥ 70
Must not have
History of resistance to two or more classes of antiretroviral drugs
History of prior receipt of an experimental HIV-1, immunotherapeutic agent, or gene therapy product
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days after the infusion
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to use engineered T cells to target and eliminate HIV-infected cells in individuals living with HIV. The study will investigate the use of cytomegalovirus-specific T cells to enhance the
Who is the study for?
This trial is for people living with HIV who are on anti-retroviral therapy (ART) but still have the virus in their bodies. Participants should be generally healthy and have a history of cytomegalovirus (CMV), which most HIV-positive individuals do.
What is being tested?
The study is testing CMV/HIV-CAR T Cells, a type of immunotherapy designed to target and destroy HIV-infected cells using the body's own modified T cells that can also respond to CMV, potentially leading to long-term remission of HIV.
What are the potential side effects?
Potential side effects may include immune reactions from the engineered T cells, such as fever or fatigue. There could also be risks associated with infusing these modified cells into the body.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am mostly able to care for myself.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have HIV that hasn't responded to at least two types of treatments.
Select...
I have previously received experimental HIV treatment or gene therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 28 days after the infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days after the infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose limiting toxicities (DLT)
Toxicity profile
Secondary study objectives
CD4+ T cell count and HIV RNA levels
Cytokine levels
EGFR+ CD3+ T cells
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Dose Level -1Experimental Treatment1 Intervention
EGFR+ T Cell Dose (Day 0) 5 x 10\^6 cells
Group II: Dose Level +2Experimental Treatment1 Intervention
EGFR+ T Cell Dose (Day 0) 50 x 10\^6 cells
Group III: Dose Level +1Experimental Treatment1 Intervention
EGFR+ T Cell Dose (Day 0) 25 x 10\^6 cells
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
605 Previous Clinical Trials
1,923,590 Total Patients Enrolled
John H. Baird, MDPrincipal InvestigatorCity of Hope Medical Center
David (Davey) Smith, MDPrincipal InvestigatorUCSD, San Diego Center for AIDS Research