Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559189
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
CD19x22 Chimeric Antigen Receptor T-cell Therapy CAR T in Pediatric B-ALL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase I Dose Escalation and Preliminary Efficacy Study of Bispecific CD19 and CD22 Chimeric Antigen Receptor Co-Expressing T Cells CD19x22 Chimeric Antigen Receptor T-cell Therapy CAR T in Pediatric Patients With Relapsed andor Refractory B-Cell Acute Lymphoblastic Leukemia B-ALL
Status:
RECRUITING
Status Verified Date:
2024-10
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 study will evaluate the safety and tolerability of administering a novel bispecific CD19CD22-directed CAR T cell product CD19x22 for the treatment of relapsed or refractory pediatric B-ALL
Detailed Description:
Precursor B-Cell Acute Lymphoblastic Leukemia B-ALL is the most common type of hematologic malignancy in the pediatric population ages 0-19 Despite favorable prognosis in pediatric B-ALL as a whole outcomes remain poor for patients who have relapsed or are refractory RR to standard therapies The Federal and Drug Administration FDA approved CD19-directed chimeric antigen receptor T-cell therapy CAR T cell based on an 80 remission induction rate thus expanding treatment options for this subtype of leukemia However despite the high remission rates induced by CD19-directed CAR T cell therapy the current FDA-approved chimeric antigen receptor therapies CARs have limitations associated with the durability of response Additionally relapse due to loss of the targeted antigen CD19 negative is a frequent cause of resistance to CD19-targeted cell therapy This study will investigate a novel bispecific CD19CD22-directed CAR T cell product CD19x22 This CAR T cell therapy can be used in patients with CD19-negative relapse after initial CD19-targeted cell therapy or in naive CAR T cell patients with the goal of reducing CD19-negative relapses
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