Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420076
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-14
Brief Title:
Sequential CAR-T Cells Therapy for CD5CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5CD7-Specific CAR-T Cells
Sponsor:
Essen Biotech
Organization:
Essen Biotech
Study Overview
Official Title:
This is an Open Single-arm Clinical Study to Evaluate the Efficacy and Safety of Anti-CD7CD5 CAR-T Cells in the Treatment of Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia T-ALL ETP-ALL and Lymphoblastic Lymphoma TLBL
Status:
RECRUITING
Status Verified Date:
2024-07
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:
BAH246
Brief Summary:
Chimeric antigen receptor CAR-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies Besides CD19 many other molecules such as CD22 CD30BCMACD123 etc may be the potential to develop the corresponding CAR-T cells to treat patients whose tumors express those markers In this study investigators will evaluate the safety and efficacy of Sequential CAR-T Cells Targeting CD5CD7 in patients with patients with relapsed or refractory T-ALLLBLETP-ALL The primary goal is safety assessment including cytokine storm response and any other adverse effects In addition disease status after treatment will also be evaluated
Detailed Description:
Acute lymphoblast leukemia T-ALL is a neoplastic lymphoid leukemia characterized by the proliferation of immature precursor T cells The combined chemotherapy has significantly improved the prognosis of T-acute lymphoblast leukemialymphoma However once the disease appears to be relapsedrefractory there are limited treatment options and the overall prognosis is extremely poor Therefore exploring safe and effective treatments is a critical unmet medical need The patients will receive Sequential CAR-T Cells Targeting CD5CD7 to examine the safety and possibly the efficacy of CD5 CAR T-Cells in CD5 CD7 relapsed or refractory acute leukemia
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