Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06064903
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2023-09-12
Brief Title:
CD7-CAR-T Cells in Pediatric RelapsedRefractory CD7 T-ALLLL
Sponsor:
Bambino Gesù Hospital and Research Institute
Organization:
Bambino Gesù Hospital and Research Institute
Study Overview
Official Title:
Phase III Study of Anti-CD7 Chimeric Antigen Receptor-Expressing T Cells in Pediatric Patients Affected by RelapsedRefractory CD7 T-cell Acute Lymphoblastic LeukemiaLymphoma
Status:
RECRUITING
Status Verified Date:
2023-06
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:
CD7-CAR01
Brief Summary:
The main purpose of this study is to evaluate the safety to establish the recommended dose and to evaluate the antitumor effect of CD7-CART01 in pediatric patients with relapsed or refractory RR T-cell acute lymphoblastic leukemia T-ALL or lymphoblastic lymphoma T-LL
Detailed Description:
This is an in-human open-lable single-arm single-agent Phase 12 study in pediatric patients with RR T-ALLT-LL who have failed at least one standard frontline chemotherapy or relapsed after allogeneic hematopoietic stem cell transplantation HSCT The study will consist of two phases Phase 1 and Phase 2 During the Dose Escalation portion of the trial Phase 1 up to 12 patients will receive CD7-CART01 in up to 2 dose levels until maximum tolerated dose MTD is determined If 2 DLTs are observed in the dose level 1 an additional DL0 will be explored The dose escalation phase will enroll successive cohorts of 3 up to 6 patients guided by a standard dose-finding 3 3 design Once the recommended phase 2 dose RP2D is defined the phase 2 portion of the study will enroll at the MTDRD identified in the phase I up to 26 pediatric patients for both phases and the study protocol will be amended to include additional international centers
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