CD19 Chimeric Receptor Expressing T Lymphocytes In B-Cell Non Hodgkin's Lymphoma, ALL & CLL

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT00586391
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • CD19CAR-28-zeta T cells — GENETIC
    Intravenous injection Dose Level 1: CD19CAR-28zeta - 2x10\^7 cells/m\^2 Dose Level 2: CD19CAR-28zeta - 1 x10\^8 cells/m\^2 Dose Level 3: CD19CAR-28zeta - 2x10\^8 cells/m\^2
  • Ipilimumab — DRUG
    For patients with intermediate or low grade leukemia/lymphoma, patients may receive ipilimumab once during the week 2 visit after the T cell infusion.

Study Details

Patients on this study have a type of lymph gland cancer called non-Hodgkin Lymphoma, Acute Lymphocytic Leukemia, or chronic Lymphocytic Leukemia (these diseases will be referred to as "Lymphoma" or "Leukemia"). Their Lymphoma or Leukemia has come back or has not gone away after treatment (including the best treatment known for these cancers). This research study is a gene transfer study using special immune cells. The body has different ways of fighting infection and disease. No one way seems perfect for fighting cancers. This research study combines two different ways of fighting disease, antibodies and T cells, hoping that they will work together. Antibodies are types of proteins that protect the body from bacterial and other diseases. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. Both antibodies and T cells have been used to treat patients with cancers; they have shown promise, but have not been strong enough to cure most patients. T lymphocytes can kill tumor cells but there normally are not enough of them to kill all the tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person. The antibody used in this study is called anti-CD19. It first came from mice that have developed immunity to human lymphoma. This antibody sticks to cancer cells because of a substance on the outside of these cells called CD19. CD19 antibodies have been used to treat people with lymphoma and Leukemia. For this study anti-CD19 has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. In the laboratory, investigators have also found that T cells work better if they also put a protein that stimulates T cells called CD28. Investigators hope that adding the CD28 might also make the cells last for a longer time in the body. These CD19 chimeric receptor T cells with C28 T cells are investigational products not approved by the Food and Drug Administration. The purpose of this study is to find the biggest dose of chimeric T cells that is safe, to see how the T cell with this sort of chimeric receptor lasts, to learn what the side effects are and to see whether this therapy might help people with lymphoma or leukemia.

Key Dates

Start date
Feb 28, 2009
Status verified
Feb 2026
Primary completion
Jul 31, 2014
Completion
Jul 31, 2029

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CD19CAR-28-zeta T cells
    Three dose levels of CTLs will be evaluated. Each patient will receive one injection according to their assigned dose over 1-10 minutes IV. \*At the discretion of the attending physician, if after a 4 to 6-week evaluation period the patient has had apparent clinical benefit (as determined by symptoms, physical exam or radiological studies); repeat infusions separated by 4 to 6 weeks (up to a maximum of 3 extra doses) of modified T cells at the same dose level or below the patient's original dose can be administered.

Primary Outcome Measure

Adverse Event Data per Patient [ Time Frame: 6 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Houston Methodist HospitalHoustonTexas77030-
Texas Children's HospitalHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Houston Methodist Hospital· Houston, TXTexas Children's Hospital· Houston, TX

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