Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316856
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-03-10
Brief Title:
CD5 Chimeric Antigen Receptor CAR T Cells in Subjects With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia
Sponsor:
Beijing GoBroad Hospital
Organization:
Beijing GoBroad Hospital
Study Overview
Official Title:
CD5 Chimeric Antigen Receptors CAR T Cells in Subjects With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia a Single-center Open-label Non-randomized Phase 12 Clinical Trial
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:
None
Brief Summary:
This is a single-center open-label non-randomized phase 12 study of anti-CD5 CAR-T cell therapy in patients with CD5 relapsed or refractory T-cell malignancies A bayesian optimal interval BOIN 12 design will be used to explore the optimal biological dose OBD from starting dose level 1 1106 20 to dose level 2 2106 20 in three cohorts autologous previous-transplant-donor or newly matched donor-derived CD5 CAR T cells If the manufactured cells are not sufficient to meet the preassigned standard dose criteria patients will be given infusion at a low dose level of 5105 20 kg The primary objective is to evaluate the safety and tolerability of CD5 CAR T cell therapy in subjects determine the OBD and recommend phase 2 dose RP2D in phase 1 and evaluate the efficacy of CD5 CAR T cell therapy in phase 2 The primary endpoint is the type and incidence of dose-limiting toxicity DLT within 28 days and the incidence and severity of adverse events AEs within 30 days after CD5 CAR T-cell infusion in phase 1 the best overall response BOR at 3 months 1 week after CD5 CAR T-cell infusion in phase 2 A total number of 54 subjects will be enrolled
Detailed Description:
None
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