Gene Therapy for Lymphoma in HIV Patients

Palo Alto (17 mi)

Overseen byMehrdad Abedi

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: AIDS Malignancy Consortium

No Placebo Group

Trial Summary

What is the purpose of this trial?This phase I/II trial studies the side effects and best dose of gene therapy in treating patients with human immunodeficiency virus (HIV)-related lymphoma that did not respond to therapy or came back after an original response receiving stem cell transplant. In gene therapy, small stretches of deoxyribonucleic acid (DNA) called "anti-HIV genes" are introduced into the stem cells in the laboratory to make the gene therapy product used in this study. The type of anti-HIV genes and therapy in this study may make the patient's immune cells more resistant to HIV-1 and prevent new immune cells from getting infected with HIV-1.

Eligibility Criteria

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.

Inclusion Criteria

My cancer is partially responding to treatment.

My cancer returned after it was initially gone.

My cancer is in remission but considered high-risk.

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

I am 18 years old or older.

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

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

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

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

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

I am on HIV medication but not taking certain drugs.

My HIV viral load meets the trial's requirements.

Exclusion Criteria

I do not have any active infections.

I have had a seizure in the last year.

I had severe bladder inflammation from previous chemotherapy.

I cannot undergo stem cell collection due to health reasons.

My bone marrow has abnormal cells not caused by lymphoma.

I currently have active brain or spinal cord disease.

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

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

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

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

I have had brain complications due to HIV.

Treatment Details

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.

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.