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Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen (MAGENTA)

Diseases

This study enrolls patients who have a type of blood cancer called T-cell leukemia or lymphoma (lymph gland cancer).

Description

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-CD5. It first came from mice that have developed immunity to human leukemia. This antibody sticks to T-cell leukemia or lymphoma cells because of a substance on the outside of these cells called CD5. CD5 antibodies have been used to treat people with T-cell leukemia and lymphoma. For this study, anti-CD5 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, the investigators have also found that T cells work better if proteins that stimulate T cells are also added, such as one called CD28. Adding the CD28 makes the cells grow better and last longer in the body, thus giving the cells a better chance of killing the leukemia or lymphoma cells.

In this study investigators are going to attach the CD5 chimeric receptor with CD28 added to it to the patient's T cells. The investigators will then test how long the cells last. These CD5 chimeric receptor T cells with CD28 are investigational products not approved by the Food and Drug Administration.

Eligibility Criteria

  • Ages Eligible for Study: up to 75 years
  • Sexes Eligible for Study: All
  • Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma (T-NHL, including Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia/lymphoma, T cell prolymphocytic leukemia with symptomatic disease, Extranodal NK/T cell lymphoma, Mycosis fungoides/ Sezary Syndrome Stage IIB or higher)
    • AND Suitable for allogeneic HSCT with confirmation of an identified eligible allo-HSCT donor by a FACT accredited transplant center
    • AND with confirmation that the center plans to proceed with transplant if CD5.CAR treatment induces a complete remission.
  • CD5-positive tumor (result can be pending at this time). > 50% CD5 + blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry/Pathology laboratory.
  • Age less than or equal to 75 years old. NOTE: The first six (6) patients treated on the study will be adults (>18 yrs of age). Six adolescents (age 12-18) will be treated before children (>3 yrs of age) are eligible.
  • Hgb greater than or equal to 7.0 (can be transfused)
  • Life expectancy greater than 12 weeks
  • If pheresis required to collect blood:
    • Creatinine <1.5 × upper limit normal
      • AST <1.5 × upper limit normal
        • PT and APTT <1.5 × upper limit normal

Detailed inclusion and exclusion criteria as listed on clinicaltrials.gov.

Contact

Rayne Rouce, MD
rhrouce@texaschildrens.org
832-824-4716

or

Josalind Randall
jxrandal@texaschildrens.org
832-824-6835