Infusion of Allogeneic Umbilical Cord Blood-Derived Cluster of Differentiation Antigen 19 (CD19)-Specific T Cells
NCT01362452 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2017-08-03
Summary
The goal of this clinical research study is to learn if an infusion of white blood cells (called T cells) that have been genetically changed is safe to give patients who have received an umbilical cord blood transplant (UCBT). Researchers want to learn if these genetically changed T-cells are effective in attacking cancer cells in patients with advanced B-cell lymphoma or leukemia after they have received an UCBT, how long the changed T-cells stay in the body, and if adding them to standard transplant could improve how patients respond to treatment.
Funding Source - FDA OOPD
Conditions
Interventions
- GENETIC
-
T-Cell Infusion
Infusion of CD19-specific T cells derived from cord blood (CB) 42 days following stem cell transplantation.
- PROCEDURE
-
Cord Blood Infusion
Cord blood infusion on Day 0.
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Elizabeth Shpall, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Year
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-12-07
- Primary Completion
- 2017-07-25
- Completion
- 2017-07-25
- FDA Drug
- Yes
Countries
- United States
Study Locations
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