Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05922384
Status:
RECRUITING
Last Update Posted:
2023-06-28
First Post:
2023-06-16
Brief Title:
Safety and Efficacy Study of KL-7SHRNA Injection Solution in the Treatment of AIDS Patients With Lymphoma
Sponsor:
Affiliated Hospital of Guangdong Medical University
Organization:
Affiliated Hospital of Guangdong Medical University
Study Overview
Official Title:
Safety and Efficacy Study of KL-7SHRNA Injection Solution in the Treatment of AIDS Patients With Lymphoma
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot clinical trial studies gene therapy in treating patients with HIV-1 infecetion combined with lymphoma undergoing 7shRNA lentiviral vector transduced CD34 hematopoietic stem cell transplant Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them After treatment CD34hematopoietic stem cells are mobilized and collected from the patients peripheral blood The CD34stem cells are then isolated and transduced with lenti-7shRNA vector and reinfused to the patient to replace the blood-forming cells that were destroyed by the chemotherapy
Detailed Description:
Primary objectives
1 To determine the safety and feasibility of using lenti-7shRNA transduced hematopoietic stemprogenitor cells in the setting of autologous hematopoietic cell transplantation for treatment of HIV infection combined with lymphoma The safety of the genetically modified product used in the transplant procedure will be assessed by monitoring each subject for adverse events procedure related toxicity absolute neutrophil count ANCplatelet engraftment sustained recovery and evidence of replication competent vector or vector recombination with the human immunodeficiency virus HIV quasi-species present in the patient
2 To determine the quantity and duration of vector-marked peripheral blood cells and to characterize the duration and level of gene marking and expression of the anti-HIV shRNA in these transduced cells and the characterization of the integration sites of vector sequences in circulating cells if there is a clinical syndrome suggestive of a clonal expansion of hematopoietic cells In addition the feasibility of the process will be assessed based on the results of the release testing of the transduced cells prior to injection into the patient
3 To measure the effect of HIV infection on the presence of HIV-resistant blood cells as measured by genetic marking for vector sequences before and after antiviral treatment interruption
1 To determine the safety and feasibility of using lenti-7shRNA transduced hematopoietic stemprogenitor cells in the setting of autologous hematopoietic cell transplantation for treatment of HIV infection combined with lymphoma The safety of the genetically modified product used in the transplant procedure will be assessed by monitoring each subject for adverse events procedure related toxicity absolute neutrophil count ANCplatelet engraftment sustained recovery and evidence of replication competent vector or vector recombination with the human immunodeficiency virus HIV quasi-species present in the patient
2 To determine the quantity and duration of vector-marked peripheral blood cells and to characterize the duration and level of gene marking and expression of the anti-HIV shRNA in these transduced cells and the characterization of the integration sites of vector sequences in circulating cells if there is a clinical syndrome suggestive of a clonal expansion of hematopoietic cells In addition the feasibility of the process will be assessed based on the results of the release testing of the transduced cells prior to injection into the patient
3 To measure the effect of HIV infection on the presence of HIV-resistant blood cells as measured by genetic marking for vector sequences before and after antiviral treatment interruption
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None