Trials / Active Not Recruiting

Active Not RecruitingNCT02051257

Memory Enriched T Cells Following Stem Cell Transplant in Treating Patients With Recurrent B-Cell Non-Hodgkin Lymphoma

Phase I Study of Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a CD19-Specific, Hinge-Optimized, CD28-Costimulatory Chimeric Receptor and a Truncated EGFR Following Peripheral Blood Stem Cell Transplantation for Patients With High-Risk Intermediate or High Grade B-Lineage Non-Hodgkin Lymphoma

Status: Active Not Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 51 (estimated)

Sponsor: City of Hope Medical Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase I trial studies the highest possible dose of memory enriched T cells that can be given following standard stem cell transplant before unmanageable side effects are seen in patients with B-cell non-Hodgkin lymphoma that has returned after previous treatment. A T cell is a type of immune cell that can recognize and kill abnormal cells of the body. Memory enriched T cells will be made from a patient's own T cells that are genetically modified in a laboratory. This means that the T cells are changed by inserting additional pieces of deoxyribonucleic acid (genetic material) into the cell to make it recognize and kill lymphoma cells. Memory enriched T cells may kill the cells that are not killed by stem cell transplant and may lower the chances of the cancer recurring.

Detailed description

PRIMARY OBJECTIVES: I. To assess the safety and determine the maximum tolerated dose (MTD) of each cellular immunotherapy product, cluster of differentiation (CD)19R (EQ) 28 zeta/truncated human epidermal growth factor receptor (EGFRt) + central memory T cell (Tcm) (Arm 1) and CD19R(EQ)28zeta/EGFRt+ naive memory T cell (TN/MEM) (Arm 2), in conjunction with a standard myeloablative autologous hematopoietic stem cell transplant (HSCT) for patients with high-risk intermediate or high grade B-lineage non-Hodgkin lymphomas. SECONDARY OBJECTIVES: I. To determine the tempo, magnitude, and duration of engraftment of the transferred T cell product as it relates to the number of cells infused. II. To study the impact of this therapeutic intervention on the development of normal CD19+ B-cell precursors in the bone marrow as a surrogate for the in vivo effector function of transferred autologous CD19R(EQ)28zeta/EGFRt+ Tcm or TN/MEM. OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 arms. ARM 1: Patients receive autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing TCM-enriched T cells intravenously (IV) over 10 minutes on day 2 or 3 following HSCT. ARM 2: Patients receive autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing TN/MEM-enriched T cells IV over 10 minutes on day 2 or 3 following HSCT. Patients who experience disease progression and have not experienced serious treatment-related toxicities at greater than or equal to 100 days post T cell infusion will be allowed to receive an optional second T cell infusion. After completion of study treatment, patients are followed up within 18-24 hours, then 18-72 hours, weekly for 1 month, monthly for 1 year, at 18, 24, and 36 months, and then annually thereafter for a minimum of 15 years.

Conditions

Interventions

Type	Name	Description
BIOLOGICAL	Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells	Given IV
BIOLOGICAL	Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

Start date: 2014-06-19
Primary completion: 2027-03-02
Completion: 2027-03-02
First posted: 2014-01-31
Last updated: 2026-03-31

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT02051257. Inclusion in this directory is not an endorsement.