Viewing Study NCT05535855



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Last Modification Date: 2024-10-26 @ 2:41 PM
Study NCT ID: NCT05535855
Status: RECRUITING
Last Update Posted: 2024-02-05
First Post: 2022-09-06

Brief Title: UCD19 CAR T Therapy in Adults with B-ALL and MRD Positivity in CR1
Sponsor: University of Colorado Denver
Organization: University of Colorado Denver

Study Overview

Official Title: Phase I Safety and Tolerability Trial of CD19 Directed CAR T Cells in Adult Patients with B-Cell Acute Lymphoblastic Leukemia B-ALL with Minimal Residual Disease MRD Positivity At First Complete Remission
Status: RECRUITING
Status Verified Date: 2024-09
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 open-label single arm Phase I trial aims to determine the safety and tolerability of anti-CD19 chimeric antigen receptor-expressing CAR T cells UCD19 CAR T in adults B-ALL that are in first complete remission with minimal residual disease MRD positivity This trial will enroll 10 patients for apheresis and treatment with lymphodepleting chemotherapy followed by UCD19 CAR T cell infusion Patients will be assessed for dose limiting toxicities DLTs within 42 days after CAR T infusion duration of B cell aplasia overall response rate at 1- 3- 6- and 12-months and overall survival and event free survival at 12- and 24- months post UCD19 CAR T infusion
Detailed Description: None

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