Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT04384393
Status:
UNKNOWN
Last Update Posted:
2022-01-11
First Post:
2020-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of ThisCART19 in Patients With Refractory or Relapsed B Cell Malignancies
Sponsor:
Fundamenta Therapeutics, Ltd.
Organization:
Study Overview
Official Title:
A Study to Evaluate the Safety and Clinical Activity of Allogeneic Chimeric Antigen Receptor T Cells Targeting CD19 in Patients With Refractory or Relapsed B Cell Malignancies.
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
RECRUITING
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 study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell malignancies.
Detailed Description:
This is a single-center, nonrandomized, open-label study to evaluate the safety and clinical activity of ThisCART19 in patients with refractory or relapsed CD19 positive B cell malignancies, such as acute or chronic lymphocytic leukemia, lymphoma and etc. The dose range is 0.2-60 x 10\^6 cells per kg body weight.
Study Oversight
Has Oversight DMC:
False
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?: