Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326463
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-03-15
Brief Title:
CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The study participant has one of the following blood cancers acute myelogenous leukemia AMLmyelodysplastic syndrome MDS acute lymphoblastic leukemia B-ALL T-ALL or Lymphoma Your cancer has been difficult to treat refractory or has come back after treatment relapse
Primary Objective
To determine the safety and maximum tolerated dose of intravenous infusions of escalating doses of CD70-CAR T cells in patients 21 years with recurrentrefractory CD70 hematological malignancies after lymphodepleting chemotherapy
Secondary Objectives
To evaluate the antileukemic activity of CD70-CAR T cells We will determine the anti- leukemic activity of the CD70-CAR T cells in the bone marrow and in the treatment of extramedullary disease
Primary Objective
To determine the safety and maximum tolerated dose of intravenous infusions of escalating doses of CD70-CAR T cells in patients 21 years with recurrentrefractory CD70 hematological malignancies after lymphodepleting chemotherapy
Secondary Objectives
To evaluate the antileukemic activity of CD70-CAR T cells We will determine the anti- leukemic activity of the CD70-CAR T cells in the bone marrow and in the treatment of extramedullary disease
Detailed Description:
The primary interventions are a lymphodepleting chemotherapy regimen fludarabine and cyclophosphamide followed by a single autologous infusion of CD70-CAR T cells
Phase I study evaluating three 3 dose levels of CD70-CAR T cells
Phase I study evaluating three 3 dose levels of CD70-CAR T cells
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03240 | OTHER | NCI Clinical Trial Registration Program | None |