Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412458
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-04-23
Brief Title:
IM83 Clinical Study of CAR-T Cell Therapy in Patients With Relapsed or Refractory Osteosarcoma
Sponsor:
Beijing Immunochina Medical Science Technology Co Ltd
Organization:
Beijing Immunochina Medical Science Technology Co Ltd
Study Overview
Official Title:
Phase I Clinical Study to Evaluate the Safety and Efficacy of IM83 CAR-T Cells for the Treatment of Relapsed or Refractory Osteosarcoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
The purpose of this study a single-center open single-dose clinical study was to evaluate the safety tolerability and pharmacokinetic profile of IM83 CAR-T cells in the treatment of patients with relapsed or refractory osteosarcoma
Detailed Description:
This study is planned to enroll 9-18 patients with relapsed or refractory osteosarcoma in a modified 33 design for dose escalation with three dose groups of 5108 cells 1109 cells and 2109 cells3-6 subjects are planned to be enrolled in each dose group to assess their safety Each dose group is planned to enroll 3-6 subjects to assess safety and if the incidence of horizontal dose-limiting toxicity DLT is 16 within 28 days after transfusion in a dose group the transfusion of cells from the next dose group can be initiated
This study will be divided into a screening period a cell collection period a chemotherapy pretreatment period a return infusion and a follow-up period and within 28 days of return infusion the investigator will assess whether a DLT Dose limited toxicity event has occurred to confirm the safety of this dose group
This study will be divided into a screening period a cell collection period a chemotherapy pretreatment period a return infusion and a follow-up period and within 28 days of return infusion the investigator will assess whether a DLT Dose limited toxicity event has occurred to confirm the safety of this dose group
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