CD19-specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies

Summary

Sometimes researchers change the DNA (genetic material in cells) of donated T cells (white blood cells that support the immune system) using a process called "gene transfer." Gene transfer involves drawing blood from the patient, and then separating out the T-cells using a machine. Researchers then perform a gene transfer to change the T-cells' DNA, and then inject the changed T-cells into the body of the patient.

The goal of this clinical research study is to learn if an investigational type of gene transfer can be given reliably and safely in patients with advanced B-cell lymphoma. B cells are a type of white blood cell that fights infection and disease. Lymphoma is a type of cancer that affects the immune system, including B cells.

The gene transfer involves drawing blood, separating out T cells (white blood cells that fight infection and disease), changing the T cells' DNA (genetic material) in a specific way, and returning the changed T cells back to the body.

Researchers want to learn the highest dose of the changed T cells that can be given safely. Researchers also want to learn how long the changed T cells remain in the participant's body, and if the changed T cells can reliably treat B-cell lymphoma. Finally, researchers want to learn if interleukin-2 (IL-2) can help the changed T cells last longer in the body.

Conditions

• Lymphoma
• B-cell Lymphoma

Interventions

PROCEDURE

Leukapheresis

Leukapheresis #1 - For Collecting T Cells Leukapheresis #2 - For Collecting Stem Cells, month following #1 Blood drawn through vein, passed through a machine to collect specific blood cells, then remaining blood returned, about 3 hours to complete.

PROCEDURE

Stem Cell Transplant

Stem cell infusion by vein over 30-45 minutes on Day 0

PROCEDURE

CD19-specific T Cell Infusion

T Cell Infusion (Gene Transfer) by vein over 15-30 minutes sometime between Day +2 through Day +7.

DRUG

IL-2

Group 2 or 4, IL-2 dose of 0.3 x 10\^6 U/m\^2 injected under skin, once a day for up to 14 days; first dose on day of T cell infusion.

DRUG

Carmustine

300 mg/m\^2 IV over 1 hour on Day -6

DRUG

Etoposide

200 mg/m\^2 IV over 3 hours every 12 hours on Days -5 to -2

DRUG

Cytarabine

200 mg/m\^2 by vein over 1 hour every 12 hours on Days -5 to -2.

DRUG

Melphalan

140 mg/m\^2 IV over 30 minutes on Day -1

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Alaunos Therapeutics

  collaborator INDUSTRY

• Intrexon Corporation

  collaborator INDUSTRY

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Partow Kebriaei, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-06-20

Primary Completion

2020-04-23

Completion

2020-04-23

FDA Drug

Yes

Countries

• United States

Study Locations