← Back to Search

CAR T-cell Therapy

Donor-Derived T-cell Therapy for HIV

Phase 1

Recruiting

Led By Richard Ambinder, MD, PhD

Research Sponsored by Catherine Bollard

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Potential participant must have adequate organ function for standard of care alloBMT according to JHU criteria.

Hematologic malignancy that qualifies for standard of care alloBMT according to JHU criteria.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is testing a new HIV therapy that uses T-cells from a donor. The trial will study the safety and effectiveness of this new therapy in people who have had a bone marrow transplant.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed here, typical risks may include reactions at the infusion site, general discomfort or pain, potential infection risk due to immune response alteration, and possible unforeseen impacts on organ functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My organs are healthy enough for a bone marrow transplant.

Select...

My blood cancer qualifies for a bone marrow transplant.

Select...

I am 18 years old or older.

Select...

I am eligible and have agreed to donate stem cells for a transplant following JHU's guidelines.

Select...

I am able to care for myself but may not be able to do active work.

Select...

I have confirmed HIV-1 infection.

Select...

I am not pregnant or breastfeeding.

Select...

I am taking 0.5 mg/kg/day or less of prednisone.

Select...

I am on effective HIV medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Any ≥ Grade 3 Adverse Events (as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0)

Secondary outcome measures

The HIV reservoir measurements

The feasibility of manufacturing of DD HST-NEETs

Trial Design

1Treatment groups

Experimental Treatment

Group I: Donor Derived HIV-Specific T-cells (DD HST-NEETs)Experimental Treatment1 Intervention

Participants who meet specified inclusion criteria including neutrophil recovery post-transplant and for whom donor products have passed release testing will receive DD HST-NEETs at a dose of 2x107/m2 within 30 days of screening visit.

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Catherine BollardLead Sponsor

13 Previous Clinical Trials

323 Total Patients Enrolled

Richard Ambinder, MD, PhDPrincipal InvestigatorJohns Hopkins University

Michael Keller, MDPrincipal InvestigatorCNMC

3 Previous Clinical Trials

115 Total Patients Enrolled

Media Library

HIV Clinical Trial 2023: DD HST-NEETs Highlights & Side Effects. Trial Name: NCT04248192 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently receiving treatment in this experiment?

"Affirmative. Data hosted on clinicaltrials.gov verifies that this research venture, which was first created on May 1st 2020, is actively recruiting participants. 8 people need to be sourced from two distinct medical centres."

Answered by AI

Has the Drug and Food Administration sanctioned DD HST-NEETs for medical use?

"Our assessment at Power placed DD HST-NEETs on the lower end of safety, with a score of 1. This reflects this protocol's Phase 1 status, which suggests limited data to support both efficacy and security."

Answered by AI

Are there any vacancies available for this research project?

"The clinical trial is open for enrollment, as attested to by the records on clinicaltrials.gov from its inception date of May 1st 2020 up until March 2nd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluate the Safety, Immunologic, and Virologic Responses of Donor Derived (DD) HIV-Specific T-cells (HST) in HIV-infected Individuals Following Allogeneic Bone Marrow Transplantation (alloRESIST)

Catherine Bollard 2020. "Evaluate the Safety, Immunologic, and Virologic Responses of Donor Derived (DD) HIV-Specific T-cells (HST) in HIV-infected Individuals Following Allogeneic Bone Marrow Transplantation (alloRESIST)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04248192.