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Virus Therapy

Gene Therapy for Lymphoma in HIV Patients

Phase 1 & 2

Waitlist Available

Led By Mehrdad Abedi

Research Sponsored by AIDS Malignancy Consortium

Eligibility Criteria Checklist

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

Must have

- In partial remission

- Relapsed after initial complete remission

Must not have

Symptomatic/active bacterial, fungal, or opportunistic infection

Seizures within the past 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new gene therapy for HIV-related lymphoma. The therapy involves inserting anti-HIV genes into the patient's stem cells in the laboratory. The goal is to make the patient's immune cells more resistant to HIV-1 and prevent new immune cells from getting infected with HIV-1.

Who is the study for?

Adults over 18 with HIV-related lymphomas that have relapsed or didn't respond to treatment, who are now receiving a stem cell transplant. They must be on stable antiretroviral therapy, have good organ function and performance status, and agree to use contraception. Excluded are those with severe health issues like dementia, uncontrolled infections, recent heart problems, or other cancers.

What is being tested?

The trial is testing gene therapy using 'anti-HIV genes' in stem cells for patients with HIV-related lymphoma undergoing stem cell transplants. The aim is to make immune cells resistant to HIV-1 infection. It includes lab analysis of biomarkers and various chemotherapy drugs alongside the transplantation procedure.

What are the potential side effects?

Potential side effects may include reactions related to the infusion of modified cells, effects from chemotherapy such as nausea, fatigue, hair loss and increased risk of infections due to weakened immunity. Specific side effects will depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is partially responding to treatment.

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My cancer returned after it was initially gone.

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My cancer is in remission but considered high-risk.

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My kidney function, measured by creatinine, is within normal limits.

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I am 18 years old or older.

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My cancer responded to the second round of treatment after the first failed.

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My lymphoma is confirmed by biopsy to be plasmablastic or peripheral T cell type.

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My cancer went away, came back, and is now gone again.

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My cancer has returned after a period of no signs of disease.

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I am mostly able to care for myself and carry out daily activities.

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I am on HIV medication but not taking certain drugs.

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My HIV viral load meets the trial's requirements.

Exclusion Criteria

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

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I do not have any active infections.

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I have had a seizure in the last year.

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I had severe bladder inflammation from previous chemotherapy.

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I cannot undergo stem cell collection due to health reasons.

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My bone marrow has abnormal cells not caused by lymphoma.

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I currently have active brain or spinal cord disease.

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I have an active CMV infection affecting my eyes or other organs.

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More than 5% of my bone marrow cells are cancerous before stem cell collection.

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I had a relapse of pneumocystis pneumonia in the last year.

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I have severe, ongoing diarrhea that affects my body's salt balance or lowers my protein levels.

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I have had brain complications due to HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 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

Percentage of Participants Who Achieve a Timely Engraftment

Secondary study objectives

CD4 Count Recovery

HIV-1 Viral Load

Integration Sites of Vector Sequences in Circulating Cells

+13 more

Other study objectives

Expansion of HIV-1 Resistant Immune Cells

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: Treatment (anti-HIV gene transduced CD34+ cells)Experimental Treatment8 Interventions

Patients receive BEAM regimen administered as standard of care comprising carmustine on day -6, cytarabine BID on days -5 to -2, etoposide BID on days -5 to -2, and melphalan on day -1. Patients undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells over 1 hour.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

2016

Completed Phase 3

~3330

Autologous Hematopoietic Stem Cell Transplantation

2017

Completed Phase 3

~2090