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ACTIVE NOT RECRUITING
NCT02797470
PHASE1/PHASE2

Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant

Sponsor: AIDS Malignancy Consortium

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase I Study of Stem Cell Gene Therapy for HIV Mediated by Lentivector Transduced, Pre-Selected CD34+ Cells

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

11

Start Date

2016-06-23

Completion Date

2036-03

Last Updated

2025-04-20

Healthy Volunteers

No

Interventions

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells

DRUG

Carmustine

300 mg/m2 on Day -6, as part of BEAM and R-BEAM regimens.

DRUG

Cytarabine

100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens.

DRUG

Etoposide

VP-16: 100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens.

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Lentivirus Vector CCR5 shRNA/TRIM5alpha/TAR Decoy-transduced Autologous CD34-positive Hematopoietic Progenitor Cells

Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells

DRUG

Melphalan

140 mg/m2 on Day -1, as part of BEAM and R-BEAM regimens.

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells

Locations (4)

UC San Diego Moores Cancer Center

La Jolla, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

UCSF Medical Center-Parnassus

San Francisco, California, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States