8 Participants Needed

Donor-Derived T-cell Therapy for HIV

Recruiting at 1 trial location
RA
Overseen ByRichard Ambinder, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Catherine Bollard
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a multi-site phase 1 study of the safety, immunologic and virologic responses of ex vivo expanded donor-derived (DD) HIV-1 multi-antigen specific T-cell (HST) with non-escaped epitope targeting (NEET) therapy as a therapeutic strategy in HIV-infected individuals following Allogeneic Bone Marrow Transplantation (alloBMT).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must continue your antiretroviral therapy throughout the study.

Is donor-derived T-cell therapy for HIV safe for humans?

Donor-derived virus-specific T cells have shown similar safety profiles in managing viral infections after stem cell transplantation in children and young adults, suggesting they are generally safe for human use.12345

How is the Donor-Derived T-cell Therapy for HIV different from other treatments?

This treatment is unique because it uses donor-derived T-cells specifically designed to target multiple parts of the HIV virus, potentially preventing the virus from rebounding after stem cell transplants. Unlike traditional treatments that rely on antiretroviral drugs, this therapy aims to provide long-lasting HIV-specific immunity by eliminating newly infected cells before they can spread.46789

What data supports the effectiveness of the treatment Donor-Derived T-cell Therapy for HIV?

Research shows that donor-derived virus-specific T cells (VSTs) can effectively restore virus-specific immunity and control viral infections after stem cell transplants, with response rates of 60% to 90% in recipients. Additionally, HIV-specific T cells generated from naive T cells have been shown to suppress active HIV in laboratory settings, suggesting potential for this treatment in managing HIV.478910

Who Is on the Research Team?

Richard Ambinder – Hopkins BCMB

Richard Ambinder, MD, PhD

Principal Investigator

Johns Hopkins University

MK

Michael Keller, MD

Principal Investigator

CNMC

Are You a Good Fit for This Trial?

This trial is for HIV-infected adults who've had an allogeneic bone marrow transplant. They must be on effective antiretroviral therapy, have good organ function, no active hepatitis C or B, and a Karnofsky score of ≥ 70. Pregnant women can't participate, and participants need to agree to study requirements.

Inclusion Criteria

Serum creatinine ≤ 2x upper limit normal.
No active HCV infection. (If seropositive, participant must have no measureable HCV RNA within 30 days of enrollment).
My organs are healthy enough for a bone marrow transplant.
See 26 more

Exclusion Criteria

Donor Exclusion Criteria for Procurement for DD HST-NEETs Manufacturing:
You are not eligible to participate if you have a condition called DD HST-NEETs and require infusion treatment.
Donor exclusion criteria will be followed as per institution standard operating procedures (SOPs).
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DD HST-NEETs at a dose of 2x107/m2 within 30 days of screening visit

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

45 days

Long-term follow-up

Participants are monitored for long-term safety and virologic responses

3 years

What Are the Treatments Tested in This Trial?

Interventions

  • DD HST-NEETs
Trial Overview The trial tests donor-derived HIV-specific T-cells (DD HST-NEETs) in patients post-bone marrow transplant to see if they're safe and how they affect the immune system and HIV itself. It's a phase 1 study conducted across multiple sites.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Donor Derived HIV-Specific T-cells (DD HST-NEETs)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Catherine Bollard

Lead Sponsor

Trials
13
Recruited
290+

Published Research Related to This Trial

Allogeneic hematopoietic stem cell transplantation (HSCT) can lead to a significant reduction in detectable HIV-1 in blood and gut tissue, resulting in temporary periods of HIV-1 remission without antiretroviral therapy in two patients.
Despite the initial success, both patients experienced a rebound of the virus within two weeks after stopping treatment, indicating that long-lived HIV-1 reservoirs may still exist and contribute to viral persistence, highlighting the need for further research on these reservoirs to achieve lasting remission.
Antiretroviral-free HIV-1 remission and viral rebound after allogeneic stem cell transplantation: report of 2 cases.Henrich, TJ., Hanhauser, E., Marty, FM., et al.[2022]
In a study involving 28 patients and 32 virus-specific T cell (VST) treatments over 3 years, the average yield of viable VSTs was 1.83 million cells, with a mean purity of 62.9%, indicating a robust method for generating these cells for antiviral therapy.
The research found that the frequency of VSTs in the donor's blood, particularly for cytomegalovirus (CMV), strongly predicts the quantity of VSTs in the final product, emphasizing the importance of careful donor selection in optimizing treatment outcomes.
Identification of the best-suited donor for generating virus-specific T cells.Tasnády, S., Karászi, É., Szederjesi, A., et al.[2020]
Allogeneic hematopoietic stem cell transplantation (HSCT) has been used for decades to treat various malignancies, and there is growing interest in its potential for HIV-1-infected patients, especially as their risk for cancer increases due to improved life expectancy from antiretroviral therapy.
The review analyzes over 25 years of data on HSCT in HIV-1 patients, suggesting that while previous attempts to use HSCT for HIV treatment were largely unsuccessful, there may be new strategies to effectively target the HIV-1 reservoir in conjunction with HSCT.
Allogeneic haematopoietic stem cell transplantation in patients with human immunodeficiency virus: the experiences of more than 25 years.Hütter, G., Zaia, JA.[2021]

Citations

Antiretroviral-free HIV-1 remission and viral rebound after allogeneic stem cell transplantation: report of 2 cases. [2022]
Identification of the best-suited donor for generating virus-specific T cells. [2020]
Allogeneic haematopoietic stem cell transplantation in patients with human immunodeficiency virus: the experiences of more than 25 years. [2021]
HIV-Specific T Cells Generated from Naive T Cells Suppress HIV In Vitro and Recognize Wide Epitope Breadths. [2021]
T cells for viral infections after allogeneic hematopoietic stem cell transplant. [2021]
Third-Party and Patient-Specific Donor-Derived Virus-Specific T Cells Demonstrate Similar Efficacy and Safety for Management of Viral Infections after Hematopoietic Stem Cell Transplantation in Children and Young Adults. [2023]
Off-the-shelf third-party HSC-engineered iNKT cells for ameliorating GvHD while preserving GvL effect in the treatment of blood cancers. [2022]
HIV-Specific T Cells Can Be Generated against Non-escaped T Cell Epitopes with a GMP-Compliant Manufacturing Platform. [2021]
Impact of Allogeneic Hematopoietic Stem Cell Transplantation on the HIV Reservoir and Immune Response in 3 HIV-Infected Individuals. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Transplantation of CCR5∆32 Homozygous Umbilical Cord Blood in a Child With Acute Lymphoblastic Leukemia and Perinatally Acquired HIV Infection. [2022]
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