Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05432401
Status:
RECRUITING
Last Update Posted:
2022-06-27
First Post:
2022-06-10
Brief Title:
TAA05 Injection in the Treatment of Adult Patients With FLT3-positive RelapsedRefractory Acute Myeloid Leukemia
Sponsor:
PersonGen BioTherapeutics Suzhou Co Ltd
Organization:
PersonGen BioTherapeutics Suzhou Co Ltd
Study Overview
Official Title:
Clinical Study of TAA05 Injection in the Treatment of Adult Patients With FLT3-positive RelapsedRefractory Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2022-06
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 is a single arm open-label dose-escalation clinical study with the primary objective of evaluating the safety and tolerability of TAA05 injection in adult subjects with FLT3-positive relapsedrefractory acute myeloid leukemia The secondary objectives are as follows to evaluate the in vivo expansion and persistence of FLT3-targeted chimeric antigen receptor T CAR-T cells after injection of TAA05to evaluate the proportion of FLT3-positive cells in peripheral blood after injection of TAA05to preliminarily evaluate the efficacy of TAA05 injection in adult subjects with FLT3-positive relapsedrefractory acute myeloid leukemiato evaluate the immunogenicity of TAA05 injectionand to explore the applicable dose in the formal clinical phase
Detailed Description:
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 10 108 20 108 and 40 108 CAR-T groups in order of sequence And the subjects will be administered once 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
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?:
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