Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514794
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
A Phase 2 Study of WU-CART-007 an Anti-CD7 Allogeneic CAR-T Cell Therapy inT-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Study of WU-CART-007 an Anti-CD7 Allogeneic CAR-T Cell Therapy in Patients With RelapsedRefractory Cell Acute Lymphoblastic Leukemia T-ALLLymphoblastic Lymphoma LBL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
The main purpose of this study is to evaluate the Composite Complete Remission Rate CRc of WU-CART-007 in RelapsedRefractory RR T-Cell Acute Lymphoblastic Leukemia T-ALLLymphoblastic Lymphoma LBL patients and to evaluate the efficacy of WU-CART-007 to induce complete Minimum Residual Disease MRD negative response
Detailed Description:
This is a Phase 2 single-agent study in patients with RR T-ALLLBL and T-ALLLBL in remission but remaining MRD positive
The study is divided into 2 disease Cohorts The RelapsedRefractory RR Cohort will evaluate patients with relapsed or refractory disease defined as 5 blast in the BM andor extramedullary disease EMD only An exploratory MRD positive cohort will evaluate patients in complete remission with MRD positive disease 01 but 5 blasts in the BM
Data for each age group will be reviewed by the Data Safety Committee DSC following enrollment of 12 patients
The study is divided into 2 disease Cohorts The RelapsedRefractory RR Cohort will evaluate patients with relapsed or refractory disease defined as 5 blast in the BM andor extramedullary disease EMD only An exploratory MRD positive cohort will evaluate patients in complete remission with MRD positive disease 01 but 5 blasts in the BM
Data for each age group will be reviewed by the Data Safety Committee DSC following enrollment of 12 patients
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