Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OZ1 transduced cells · 1 trial · 1 indication
Percentage of participants with clonal expansion of cells with a predominant OZ1 insertion site was reported. A predominant integration site was defined as an integration site which has a density of at least 50 percent (%) of the total signal detected by polymerase chain reaction (PCR), when the percentage of cells marked by vector was greater than (\>)1% of the test cell population.
Percentage of participants with insertional oncogenesis by clonal expansion of cells modified with OZ1/LNL6 were reported.
OZ1 and LNL6 marking analysis were performed by quantitative deoxyribonucleic acid-polymerase chain reaction (DNA-PCR). Number of participants in each of 3 categories for gene detection: Not Detected, Detected (1, 2 and 3 of the 3 triplicates of the sample were detected respectively \[1/3 Detected, 2/3 Detected, 3/3 Detected\]) and Detected (Quantifiable) were reported for marking of gene transfer product in PBMC.
| Arm | Type | Description |
|---|---|---|
| Anti-HIV-1 Ribozyme (OZ1) transduced cells | OTHER | OZ1 transduced cells Long term follow up of previously infused OZ1 transduced cells |
| Name | Type | Description |
|---|---|---|
| OZ1 transduced cells | GENETIC | Long term follow up of previously infused OZ1 transduced cells |
Inclusion Criteria: * All patients who were enrolled (between 18 and 45 years of age) in the base study "OTH/OZ1-INT-1" (NCT00074997) will be invited to participate in this long term follow-up study * Patients must have received the Final Cell Product infusion in base study "OTH/OZ1-INT-1" * Have s...
OZ1 transduced cells is an investigational gene therapy being studied for the treatment of HIV-1 infection. It is intended for patients who are HIV-1 positive. The therapy is currently in clinical development and has not been approved for commercial use.
OZ1 transduced cells is being developed by Johnson & Johnson, a company publicly traded under the ticker symbol JNJ. The therapy is in Phase 2 clinical development for the treatment of HIV-1 infection.
OZ1 transduced cells is in Phase 2 clinical development. It is an investigational gene therapy for HIV-1 infection and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to evaluate its safety and efficacy.
OZ1 transduced cells has been studied in one clinical trial with the identifier NCT01177059. This was a Phase 2, long-term follow-up study in HIV-1 positive patients who had received the gene therapy. The trial was completed and enrolled 68 participants in the United States and Australia.
OZ1 transduced cells is a gene therapy product that involves cells transduced with the OZ1 construct. The clinical trial NCT01177059 refers to the therapy as OZ1 gene therapy. The product is being developed by Johnson & Johnson for HIV-1 infection.