Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519565
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Safety and Efficacy of PRG-1801 in RecurrentRefractory Immune Thrombocytopenia ITP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Study on the Safety and Efficacy of PRG-1801 for the Treatment of RecurrentRefractory Immune Thrombocytopenia ITP
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single center open-label 33 dose escalation early phase 1 study to evaluate the safety tolerability and preliminary efficacy of PRG-1801 for patients with relapsedrefractory immune thrombocytopenia ITP
Detailed Description:
This investigator-initiated clinical study aims to evaluate PRG-1801 a BCMA-targeted CAR-T cell therapy in patients with relapsed refractory immune thrombocytopenia ITP The study employs a dose-escalation design to assess safety tolerability and preliminary efficacy
Approximately 1 sites are planned to be selected for the clinical trial The subjects who sign the informed consent forms and been screened by inclusionexclusion criteria will be assigned into 35106 100106 and 300106 CAR-T cells groups in order of sequence And the subjects will undergo leukapheresis lymphodepletion pre-treatment and a single infusion of PRG-1801 Dose escalation will follow 3 3 design and 3-6 subjects in each group will complete a single dose Within the same dose group the next subject will be administered after the previous subject has completed at least 14 days of safety observation After the last subject in each dose group has completed the dose-limiting toxicity DLT assessment window of 28 days after single dose the enrollment and treatment for the next dose group may be initiated after the Safety Review Committee SRC agrees to enter the next dose group based on clinical safety data assessment
When DLT occurs in 1 of 3 subjects in a dose group 3 additional subjects in the same dose group will be required up to 6 subjects in the dose group have completed DLT assessment if no DLT occurs in the additional 3 subjects dose escalation will continue if 1 of the 3 additional subjects experiences one DLT dose escalation will be discontinued if more than 1 of the 3 additional subjects experiences DLTs dose escalation will be discontinued and 3 additional subjects will be required to be enrolled at one lower dose level for DLT assessment After the end of escalation for the maximum dose group if no MTD is observed the highest dose level is defined as the MTD
Approximately 1 sites are planned to be selected for the clinical trial The subjects who sign the informed consent forms and been screened by inclusionexclusion criteria will be assigned into 35106 100106 and 300106 CAR-T cells groups in order of sequence And the subjects will undergo leukapheresis lymphodepletion pre-treatment and a single infusion of PRG-1801 Dose escalation will follow 3 3 design and 3-6 subjects in each group will complete a single dose Within the same dose group the next subject will be administered after the previous subject has completed at least 14 days of safety observation After the last subject in each dose group has completed the dose-limiting toxicity DLT assessment window of 28 days after single dose the enrollment and treatment for the next dose group may be initiated after the Safety Review Committee SRC agrees to enter the next dose group based on clinical safety data assessment
When DLT occurs in 1 of 3 subjects in a dose group 3 additional subjects in the same dose group will be required up to 6 subjects in the dose group have completed DLT assessment if no DLT occurs in the additional 3 subjects dose escalation will continue if 1 of the 3 additional subjects experiences one DLT dose escalation will be discontinued if more than 1 of the 3 additional subjects experiences DLTs dose escalation will be discontinued and 3 additional subjects will be required to be enrolled at one lower dose level for DLT assessment After the end of escalation for the maximum dose group if no MTD is observed the highest dose level is defined as the MTD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None