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Phase I Study Of CD19 Chimeric Receptor Expressing T Lymphocytes In B-Cell Non Hodgkin's Lymphoma, Acute Lymphocytic Leukemia, and Chronic Lymphocytic Leukemia


Phase 1
18 Years
N/A
Open (Enrolling)
Both
B Cell Lymphoma, Chronic Lymphocytic Leukemia

Thank you

Trial Information

Phase I Study Of CD19 Chimeric Receptor Expressing T Lymphocytes In B-Cell Non Hodgkin's Lymphoma, Acute Lymphocytic Leukemia, and Chronic Lymphocytic Leukemia


Patients will give us blood to make CD19 CD28 chimeric receptor-T cells in the laboratory.
These cells will be grown and frozen for the patient. To make the T cells investigators take
the blood and stimulate it with growth factors to make the T cells grow. To get the CD19
antibody (with CD28) to attach to the surface of the T cell, they insert the antibody gene
into the T cell. This is done with a virus called a retrovirus that has been made for this
study and will carry the antibody gene into the T cell. This virus also helps us find the T
cells in the blood after they inject them using a special laboratory test. Because the
patients will receive cells with a new gene in them they will be followed for a total of 15
years to see if there are any long term side effects of gene transfer. If the patient cannot
visit the clinic, they may be contacted by the research coordinator or physician.

When the patients enroll on this study, they will be assigned a dose of CD19 CD28 chimeric
receptor-T cells.

The investigators' studies so far have shown that the infused T cells may need to receive an
extra boost in order to expand efficiently in the body. Therefore, 2 weeks after T cell
infusion, the patient will receive one injection of a drug called ipilimumab, which they
believe will help the T cells grow. This drug is approved by the FDA to treat certain
cancers, such as melanoma, but the dose of drug used for this study will be lower than those
used in those other treatments to avoid side effects.

Patients will be given an injection of cells into the vein through an IV at the assigned
dose. The injection will take about 10 minutes. Patients will be followed in the clinic
after the injection for up to 3 hours. If after a 4-6 week evaluation period after the
infusion, the patient seems to be experiencing a benefit (confirmed by radiological studies,
physical exam and/or symptoms), they may be able to receive up to three additional doses of
the T cells if they wish. These additional infusions would be at least 4-6 weeks apart and
at the same dose level they received the first time or a lower dose. The treatment will be
given by the Center for Cell and Gene Therapy at Texas Children's Hospital or The Methodist
Hospital.

To learn more about the way the CD19 CD28 chimeric receptor-T cells are working and how long
they last in the body, extra blood will be drawn.

Inclusion Criteria


INCLUSION CRITERIA:

Patients must meet the following eligibility criteria to be included:

1. Recurrent low grade or intermediate grade B cell lymphoma or leukemia (ALL or CLL),
or newly diagnosed patients unable to receive or complete standard therapy OR
diagnosis of relapsed refractory intermediate B cell lymphoma with a treatment plan
that will include high dose therapy and autologous stem cell transplantation

2. Life expectancy of at least 12 weeks

3. Recovered from the toxic effects of all prior chemotherapy before entering this study

4. ANC greater than 500, HgB greater than 8.0

5. Bilirubin less than 3 times the upper limit of normal

6. AST less than 5 times the upper limit of normal

7. Serum creatinine less than 3 times upper limit of normal

8. Pulse oximetry of greater than 90% on room air

9. Karnofsky/Lansky score of greater than 60%

10. Available autologous transduced peripheral blood T-cells with greater than/=15%
expression of CD19CAR determined by flow-cytometry

11. Patients or legal guardians must sign an informed consent indicating that they are
aware this is a research study and have been told of its possible benefits and toxic
side effects. Patients or their guardians will be given a copy of the consent form

12. Sexually active patients must be willing to utilize one of the more effective birth
control methods during the study and for 3 months after the study is concluded. The
male partner should use a condom

EXCLUSION CRITERIA:

1. History of hypersensitivity reactions to murine protein-containing products

2. Pregnant or lactating

3. Tumor in a location where enlargement could cause airway obstruction

4. Currently receiving any investigational agents or have not received any tumor
vaccines within the previous six weeks

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse Event Data per Patient

Outcome Description:

Evaluate the safety of autologous T-lymphocytes genetically modified to express CAR targeting CD19CAR in patients with refractory/relapsed NHL, ALL or B-CLL.

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Carlos Ramos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

19384-CRETI-NH

NCT ID:

NCT00586391

Start Date:

February 2009

Completion Date:

February 2033

Related Keywords:

  • B Cell Lymphoma
  • Chronic Lymphocytic Leukemia
  • B cell Lymphoma
  • Cancer
  • Chronic Lymphocytic Leukemia
  • CD19 CHIMERIC RECEPTOR EXPRESSING T LYMPHOCYTES
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location
Methodist Hospital Houston, Texas  77030
Texas Children's Hospital Houston, Texas