Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06063317
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-09-14
Brief Title:
A Study of OnCARlytics CF33-CD19 in Combination with Blinatumomab in Adults with Advanced or Metastatic Solid Tumors OASIS
Sponsor:
Imugene Limited
Organization:
Imugene Limited
Study Overview
Official Title:
A Phase I Dose Escalation and Dose Expansion Safety and Tolerability Study of OnCARlytics CF33-CD19 Administered Intravenously or Intratumorally in Combination with Blinatumomab in Adults with Advanced or Metastatic Solid Tumors OASIS
Status:
RECRUITING
Status Verified Date:
2024-08
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:
OASIS
Brief Summary:
This is an open-label dose escalation and dose expansion multi-center phase I study evaluating the safety and tolerability of CF33-CD19 administered intravenously IV or intratumorally IT in combination with blinatumomab in adults with advanced or metastatic solid tumors
Detailed Description:
CF33-CD19 a novel chimeric orthopoxvirus will be administered as a monotherapy or in combination with blinatumomab to assess the safety and efficacy of the treatment regimens as well as immunological changes in the tumour microenvironment
Subjects eligible for treatment include those with any metastatic or advanced solid tumor who have documented radiological progression per RECIST following at least two prior lines of therapy
All enrolled monotherapy subjects will be treated with CF33-CD19 on Day 1 and 8 of Cycle 1 and then on Day 1 of each 21-day cycle thereafter Subjects treated with the combination regimen will receive CF33-CD19 on Days 1 and 15 of each 28-day cycle In addition they will receive blinatumomab as a 7-day continuous infusion from Days 2-9 and Days 16-23 of each cycle
Subjects eligible for treatment include those with any metastatic or advanced solid tumor who have documented radiological progression per RECIST following at least two prior lines of therapy
All enrolled monotherapy subjects will be treated with CF33-CD19 on Day 1 and 8 of Cycle 1 and then on Day 1 of each 21-day cycle thereafter Subjects treated with the combination regimen will receive CF33-CD19 on Days 1 and 15 of each 28-day cycle In addition they will receive blinatumomab as a 7-day continuous infusion from Days 2-9 and Days 16-23 of each cycle
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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