Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06009107
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2023-08-18
Brief Title:
A Study of HY004 Treatment in Adult RelapsedRefractory B-precursor Acute Lymphoblastic Leukemia rr B-ALL
Sponsor:
Juventas Cell Therapy Ltd
Organization:
Juventas Cell Therapy Ltd
Study Overview
Official Title:
A Phase III Single Arm Multi-center Study Evaluating the Safety and Efficacy of HY004 in Adult Patients With RelapsedRefractory B-precursor Acute Lymphoblastic Leukemia rr B-ALL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
B-ALL
Brief Summary:
This is a multi-center phase III trial to evaluate the safety and efficacy of HY004 treatment in Adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia rr B-cell ALL
Detailed Description:
This trial is a multi-center open label single-arm phase III trial to evaluate the safety and efficacy of HY004 treatment in Adult aged 1865 years old patients with rr B-cell ALL
The phase I part of the trial is to evaluate the safety optimal dose of HY004 PharmacokineticsPharmacodynamicsPKPDand preliminary efficacy in the treatment of Adult patients with rr B-cell ALL The phase II part of the trial is to evaluate the efficacy and safety of HY004 in in the treatment of Adult patients with rr B-cell ALL The study includes screening pre-treatment Cell Product manufacture lymphodepletion HY004 infusion safety and efficacy follow-up and survival follow-up All subjects who have received HY004 infusion will be followed for up to 2 years
The phase I part of the trial is to evaluate the safety optimal dose of HY004 PharmacokineticsPharmacodynamicsPKPDand preliminary efficacy in the treatment of Adult patients with rr B-cell ALL The phase II part of the trial is to evaluate the efficacy and safety of HY004 in in the treatment of Adult patients with rr B-cell ALL The study includes screening pre-treatment Cell Product manufacture lymphodepletion HY004 infusion safety and efficacy follow-up and survival follow-up All subjects who have received HY004 infusion will be followed for up to 2 years
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