Safety Study of Zinc Finger Nuclease CCR5-modified Hematopoietic Stem/Progenitor Cells in HIV-1 Infected Patients
NCT02500849 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2025-10-09
Summary
The purpose of the study is to evaluate the safety and feasibility of administering SB-728mR-HSPC after conditioning with busulfan.
Conditions
Interventions
- GENETIC
-
SB-728mR-HSPC Infusion 3 days following busulfan conditioning
Sponsors & Collaborators
-
Sangamo Therapeutics
collaborator INDUSTRY -
California Institute for Regenerative Medicine (CIRM)
collaborator OTHER -
City of Hope Medical Center
lead OTHER
Principal Investigators
-
Amrita Y. Krishnan, MD · City of Hope Medical Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-03-10
- Primary Completion
- 2026-08-24
- Completion
- 2026-08-24
Countries
- United States
Study Locations
More Related Trials
-
An Efficacy and Safety Study of shRNA-modified CD34+ Cells in HIV-infected Patients.
NCT03517631 ·Status: UNKNOWN ·Phase: PHASE1
-
A Clinical Trial to Evaluate the Safety and Immunogenicity of CH505M5 N197D mRNA-gp160 Followed by CH505 TF mRNA-gp160 in Adults in Overall Good Health Without HIV
NCT06557785 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
An Open-Label Phase I/II Study of Recombinant Granulocyte Colony Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With the Acquired Immune Deficiency Syndrome (AIDS) or Severe AIDS-Related Complex (ARC)
NCT00002255 ·Status: COMPLETED ·Phase: PHASE1
-
An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
NCT00002008 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Stem Cells and Filgrastim
NCT00001071 ·Status: COMPLETED ·Phase: NA
-
An Efficacy and Safety Study of Autologous Cluster of Differentiation 34 (CD34+) Hematopoietic Progenitor Cells Transduced With Placebo or an Anti- Human Immunodeficiency Virus Type 1 (HIV-1) Ribozyme (OZ1) in Participants With HIV-1 Infection
NCT00074997 ·Status: COMPLETED ·Phase: PHASE2
-
CD4 CAR+ ZFN-modified T Cells in HIV Therapy
NCT03617198 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Long-term Follow-up of HIV Subjects Exposed to SB-728-T or SB-728mR-T
NCT04201782 ·Status: TERMINATED
-
A Study of Granulocyte Colony-Stimulating Factor Plus Recombinant Erythropoietin Plus Zidovudine in Patients With AIDS or AIDS-Related Complex
NCT00002281 ·Status: COMPLETED ·Phase: NA
-
Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection
NCT01734850 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
CCR5-modified CD4+ T Cells for HIV Infection
NCT03666871 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Phase I/II Pilot Study of Simultaneously Administered Rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility
NCT00002006 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Effectiveness of an Adjuvant in Improving Immune Response to Hepatitis B Virus Vaccine in HIV Infected Individuals
NCT00272493 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of BAY 50-4798 in Patients With HIV Infection
NCT00059462 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Immune Response Assessment Study of Killed-whole HIV-1 Vaccine (SAV001-H) in Chronic HIV-1 Infected Patients
NCT01546818 ·Status: COMPLETED ·Phase: PHASE1
-
Gene Therapy After Frontline Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin Lymphoma
NCT01961063 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
NCT00002009 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Trial in Healthy, HIV-1-Uninfected Adult Participants to Compare the Safety, Tolerability and Immunogenicity of CH505TF gp120 Produced From Stably Transfected Cells to CH505TF gp120 Produced From Transiently Transfected Cells
NCT03856996 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of an Antibody to CCR5 in Individuals With HIV Who Are Not Currently on Antiretroviral Therapy
NCT00114699 ·Status: COMPLETED ·Phase: PHASE1
-
Safety of Transplantation of CRISPR CCR5 Modified CD34+ Cells in HIV-infected Subjects With Hematological Malignances
NCT03164135 ·Status: UNKNOWN ·Phase: NA
-
The Effectiveness of GM-CSF in HIV-Positive Patients Who Are Also Receiving Anti-HIV Therapy
NCT00000850 ·Status: COMPLETED ·Phase: PHASE2
-
Trial to Evaluate the Safety and Immunogenicity of Priming Regimens of 426c.Mod.Core-C4b and Optional Boost Regimen With HIV Trimer BG505 SOSIP.GT1.1 gp140, Both Adjuvanted With 3M-052-AF + Alum in Healthy, Adult Participants Without HIV
NCT05471076 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia
NCT00002007 ·Status: COMPLETED ·Phase: NA
-
Evaluating the Safety, Tolerability, and Immunogenicity of a Prime-Boost Regimen of HIV-1 Nef/Tat/Vif, Env pDNA Vaccine Delivered Intramuscularly With Electroporation and HIV-1 rVSV envC Vaccine in Healthy, HIV-Uninfected Adults
NCT02654080 ·Status: COMPLETED ·Phase: PHASE1
-
The Safety and Effectiveness of Injections of Human Recombinant Interferon-gamma in Patients With AIDS Who Have Taken Zidovudine
NCT00001112 ·Status: COMPLETED ·Phase: PHASE1