drugset / Trial / NCT02797470
Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant
Phase 1/2
Active not recruiting
11 enrolled
AIDS Malignancy Consortium
California Institute for Regenerative Medicine (CIRM) · collabNational Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-06-23
- Primary completion
- 2021-05-13
- Completion
- 2036-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lentivirus Vector CCR5 shRNA/TRIM5alpha/TAR Decoy-transduced Autologous CD34-positive Hematopoietic Progenitor Cells | Unknown | — | Intravenous |
| Background | Cytarabine | Small molecule | 100 mg/m2 | — |
| Background | Etoposide | Small molecule | 100 mg/m2 | — |
| Background | Melphalan | Small molecule | 140 mg/m2 | — |
| Background | carmustine | Small molecule | 300 mg/m2 | — |