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CAR T-cell Therapy
CCR5-Modified T Cell Therapy for HIV (TRAILBLAZER Trial)
Phase 1 & 2
Waitlist Available
Led By Benigno Rodriguez, MD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men or women, including trans men or women, ≥18 and ≤70 years of age.
HIV-1 infection, documented by any FDA-approved ELISA, EIA, or rapid antibody detection method, and confirmed by a second FDA-approved antibody-based test or by a positive FDA-approved HIV RNA detection assay. FDA-approved HIV-1 RNA detection assay alone constitutes proof of HIV-1 infection assuming there is documentation of >199 copies/mL of HIV-1 RNA in the absence of antiretroviral therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
TRAILBLAZER Trial Summary
This trial compared two methods of treating HIV-1 infection using autologous CD4+ T cells.
Who is the study for?
This trial is for adults aged 18-70 with well-controlled HIV on stable antiretroviral therapy, not pregnant or breastfeeding, and without significant heart issues or bleeding disorders. Participants must have good organ function, no recent major surgeries, and be willing to abstain from certain activities as required.Check my eligibility
What is being tested?
The study compares genetically modified CD4+ T cells targeting the CCR5 gene (SB-728-T) against expanded unmodified autologous CD4+ T cells in subjects with treated HIV-1 infection to see which is more effective at managing the virus.See study design
What are the potential side effects?
Potential side effects may include reactions related to cell infusions such as fever, chills, fatigue, headache or nausea. There could also be risks associated with genetic modification like unintended changes to other genes.
TRAILBLAZER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
Select...
I am HIV positive, confirmed by approved tests.
Select...
My veins are suitable for leukapheresis as confirmed by tests.
TRAILBLAZER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in the magnitude of change in intact provirus from before infusion to 96 weeks after infusion between the two study arms.
Difference in the proportion of participants who experience a grade ≥3 adverse event that is considered possibly, probably, or definitely related to study treatment between the two study arms.
Proportion of participants who experience a grade ≥3 adverse event that is considered possibly, probably, or definitely related to study treatment in each of the study arms.
Secondary outcome measures
Change in the log10 copy-number of intact proviruses per million CD4+ T cells from the first leukapheresis visit to the week 48 visit.
Change in the log10 copy-number of intact proviruses per million CD4+ T cells from the first leukapheresis visit to the week 96 visit.
Difference in the magnitude of change in intact provirus from before infusion to 48 weeks after infusion between the two study arms.
+5 moreSide effects data
From 2017 Phase 1 & 2 trial • 26 Patients • NCT0154315255%
Pyrexia
45%
Skin odour abnormal
36%
Nausea
36%
Respiratory, thoracic and mediastinal disorders
36%
Nervous system disorder
36%
Headache
27%
Alopecia
27%
Chills
27%
Fatigue
27%
Upper respiratory tract infection
18%
Sinusitis
18%
Vomiting
18%
Aspartate aminotransferase increased
18%
Alanine aminotransferase increased
18%
Diarrhoea
18%
Pain
18%
Hypertension
9%
Chest pain
9%
Syphilis
9%
Abdominal discomfort
9%
Migraine
9%
Alopecia areata
9%
Neck pain
9%
Psychiatric disorders
9%
Cough
9%
Malaise
9%
Bronchitis
9%
Urinary hesitation
9%
Sinus congestion
9%
Anal skin tags
9%
Hepatotoxicity
9%
Back pain
9%
Insomnia
9%
Oropharyngeal pain
9%
Asthenia
9%
Seasonal allergy
9%
Nasopharyngitis
9%
Tinnitus
9%
Hypogonadism
9%
Vision blurred
9%
Balanitis candida
9%
Exposure to communicable disease
9%
Hyponatraemia
9%
Arthralgia
9%
Fibrous histiocytoma
9%
Respiratory tract congestion
9%
Hyperhidrosis
9%
Hypertriglyceridaemia
9%
Procedural pain
9%
Gonorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 3 - IV Cyclophosphamide 1.0 g/m2
Cohort 1 - IV Cyclophosphamide 200 mg
Cohort 2 - IV Cyclophosphamide 0.5 g/m2
Cohort 5 - IV Cyclophosphamide 1.5 g/m2
Cohort 4 - IV Cyclophosphamide 2.0 g/m2
TRAILBLAZER Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1Experimental Treatment1 Intervention
Arm 1 (n=20) will be pretreated with cyclophosphamide 1 g/m2 and will receive a single intravenous infusion of 0.5 to 4x1010 ex vivo expanded autologous CD4+ T cells that have been transduced with a zinc finger nuclease designed to cleave CCR5.
Group II: Arm 2Active Control1 Intervention
Arm 2 (n=10) will be pretreated with cyclophosphamide 1 g/m2 and will receive a single intravenous infusion of 0.5 to 4x1010 ex vivo expanded autologous CD4+ T cells that have not been modified by zinc finger nucleases.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SB-728-T
2010
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
259,990 Total Patients Enrolled
University of CincinnatiLead Sponsor
428 Previous Clinical Trials
634,356 Total Patients Enrolled
University of California, San FranciscoOTHER
2,503 Previous Clinical Trials
15,236,625 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that causes unusual bleeding.I have not taken maraviroc or any CCR5 inhibitor in the last 4 weeks.I haven't received any vaccines in the 4 weeks before my treatment, except for a COVID-19 vaccine.I have a history of tuberculosis, treated or not.If the clinical investigator or sponsor thinks that any condition may affect the trial, you will not be able to participate.I have been on HIV treatment with undetectable levels for at least 48 weeks.I cannot use local anesthetics that contain epinephrine.You have a medical device like a pacemaker or an implantable defibrillator that can be affected by the electrical equipment used during the study.I need to take medication that affects blood clotting and can't stop it for a week.You have enough white blood cells called neutrophils in your body (more than 1500 per cubic millimeter).Your creatinine level in the blood is less than 1.5 mg/dL.I don't have any skin issues or scars that would make a spinal tap difficult.I don't have any conditions that would prevent surgery in the groin area.I can't avoid possible COVID-19 exposure after my cyclophosphamide treatment.I've been consistently taking my HIV medication as prescribed without missing doses for more than a week.I am allergic to some ingredients in the study medication.I am a woman or person born female, able to have children, and have not had certain surgeries to prevent pregnancy.I haven't had any cancer in the past 5 years, except for certain skin cancers or low-grade anal or cervical issues.I have not taken zidovudine in the last 30 days.I have a history of problems with urine flow due to an enlarged prostate.I haven't had any AIDS-defining conditions in the last 5 years, except for a low CD4+ T cell count.I have not had gene therapy that changes my DNA.I haven't had major GI surgery in the last 45 days, but minor anal procedures are okay if cleared.I do not have active hepatitis B or C, or I have successfully treated hepatitis C.I have severe heart failure or uncontrolled heart problems.I do not have an active chronic liver disease like cirrhosis.I have a serious illness that needs long-term treatment or was hospitalized recently.My doctor has cleared me despite having a brain lesion.I do not have any unresolved issues in my colon that would prevent a safe biopsy.Your liver function tests (AST and ALT) are within 2.5 times the normal range.I agree to avoid activities that could lead to conception for 90 days after receiving cyclophosphamide.Your hemoglobin level needs to be equal to or higher than 11 g/dL.I have HIV with limited treatment options due to resistance.You have a platelet count of at least 150,000 per cubic millimeter of blood.I am between 18 and 70 years old.You have read and signed a paper that explains the study and your agreement to participate in it.I am HIV positive, confirmed by approved tests.You currently use drugs or alcohol in a way that may make it difficult to follow the study guidelines.My veins are suitable for leukapheresis as confirmed by tests.I haven't taken any immune-modifying drugs or certain steroids in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2
- Group 2: Arm 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.
Who meets the qualifications for enrollment in this experiment?
"This clinical trial is aiming to recruit 30 participants infected with HIV and aged between 18-70 years old. To be considered, potential patients must have: Accessible venous systems for leukapheresis as proven by medical tests, a signed informed consent document, gender identity of male or female including trans men/women who are willing not to engage in sexual activity that may lead to pregnancy 90 days after the cyclophosphamide administration visit., HIV infection approved by FDA-approved ELISA, EIA or rapid antibody detection method followed up with another test from the same agency; ANC > 1500/mm3 , Hemoglobin level ≥11"
Answered by AI
What is the ultimate aim of this medical experiment?
"This trial is expected to last for two years and its primary outcome measures the difference in adverse events amongst participants from both study arms. Secondary objectives assess pentamer PCR-positive CD4+ T cells, rectal biopsy tissue frequency of the same antigen, and a change in IUPM CD4+ T cell numbers on QVOA assay between leukapheresis visits at month one and twelve."
Answered by AI
Is this research undertaking recruiting new participants at present?
"Unfortunately, as per the clinicaltrials.gov records, this medical trial is not taking on new participants at present. Initially posted in June 2019 and last updated in January 2022, it has already recruited its quota of patients; however there are 1181 other studies which remain open for enrollment presently."
Answered by AI
Are geriatric participants being welcomed into this clinical trial?
"To be eligible for this trial, patients must be aged between 18 and 70 years. There are separately managed trials for those below 18 (293) and above 65 (901)."
Answered by AI
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