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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.

Must not have

Participants with active acute GVHD grades II-IV

Active and uncontrolled relapse of malignancy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

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My organs are healthy enough for a bone marrow transplant.

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My blood cancer qualifies for a bone marrow transplant.

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I am 18 years old or older.

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

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

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I have confirmed HIV-1 infection.

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I am not pregnant or breastfeeding.

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

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I am on effective HIV medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have moderate to severe acute graft-versus-host disease.

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My cancer is currently growing or spreading.

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I have bronchiolitis obliterans syndrome or serositis.

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I haven't had any vaccines, including for hepatitis B or pneumonia, in the last 28 days.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

The HIV reservoir measurements

The feasibility of manufacturing of DD HST-NEETs

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 13Eligibility criteria met