Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532630
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Anti-CD19-CAR-T Cells in Subjects With RelapsedRefractory B Cell Malignancies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-CD19-CAR-T Cell Therapy in Subjects With RelapsedRefractory B Cell Malignancies
Status:
RECRUITING
Status Verified Date:
2024-07
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 is a single-center single-arm open-label exploratory study to determine the safety tolerability feasibility and preliminary anti-tumor activity of anti-CD19-CAR-T cells in subjects with relapsedrefractory rr B-cell malignancies
This study plans to enroll patients with relapsedrefractory CD19-positive B-cell malignancies who will receive a single infusion of anti-CD19-CAR-T cells after screening PBMC collection and lymphodepleting chemotherapy
This study plans to enroll patients with relapsedrefractory CD19-positive B-cell malignancies who will receive a single infusion of anti-CD19-CAR-T cells after screening PBMC collection and lymphodepleting chemotherapy
Detailed Description:
This study will enroll subjects with CD19-positive relapsedrefractory B-cell malignancies The effectiveness assessments for anti-CD19-CAR-T cell therapy is evaluated according to international criteria including the 2018 Lugano Classification Toxicity is evaluated based on the Common Terminology Criteria for Adverse Events CTCAE version 50 from the National Cancer Institute The safety of anti-CD19-CAR-T cell therapy will be evaluated through laboratory tests 12-lead EKGs and vital signs monitoring Additionally blood samples from subjects will be collected to study cellular metabolism and explore the effects of cell therapy on ferritin C-reactive protein and related cytokines
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