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CD19 CAR T Cells for B Cell Malignancies After Allogeneic Transplant

Complete title: A Phase I/II Study of Cellular Immunotherapy with Donor Central Memory-Derived Virus-Specific CD8+ T-Cells Engineered to Target CD19 for CD19+ Malignancies after Allogeneic Hematopoietic Stem Cell Transplant

Research Study Number       2494.00
Principal Investigator       Cameron Turtle, PhD, MBBS
Phase       I/II

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Research Study Description

This phase I/II trial studies the safety and toxicity of post-transplant treatment with donor T cells engineered to express a chimeric antigen receptor (CAR) targeting CD19 in patients who have had a matched related allogeneic hematopoietic stem cell transplant for a CD19+ B cell malignancy.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years to 75 Years

Genders Eligible for Study: Both

- Patients with CD19+ B cell malignancy who have persistent, relapsed or progressive disease after hematopoietic stem cell transplant from an human leukocyte antigen (HLA)-matched related donor -- OR -- patients with CD19+ B cell malignancy who are planned for or have had a hematopoietic stem cell transplant from an HLA-matched related donor and are at risk of relapse after HCT defined by any one of the disease-specific criteria listed below:

- 1. Philadelphia chromosome negative acute lymphoblastic leukemia:

-- a) Beyond first complete remission (CR) at the time of pre-transplant evaluation

-- b) Required > 1 cycle of induction chemotherapy to achieve CR

-- c) First morphologic CR but with evidence of minimal residual disease by flow cytometry, conventional cytogenetics, fluorescence in situ hybridization (FISH) or polymerase chain reaction (PCR)

-- d) First CR with poor risk cytogenetics (t(4:11), t(8;14), hypodiploidy, near triploidy or > 5 cytogenetic abnormalities) at diagnosis

-- e) Planned for or have had a reduced intensity conditioned or non-myeloablative transplant

- 2. Philadelphia positive acute lymphoblastic leukemia

-- a) Not in CR at the time of pre-transplant evaluation

-- b) In CR with the following features:

--- i) Intolerant or unwilling to use a TKI after HCT

--- ii) Current or previous detection of cytogenetic abnormalities in addition to t(9;22) by conventional karyotyping, FISH or molecular methods

- 3. Chronic lymphocytic leukemia, or low grade B cell lymphomas:

-- a) Failed or ineligible for prior immunochemotherapy that included a purine analog and anti-CD20 monoclonal antibody AND a lymph node >= 5 cm at the time of pre-transplant evaluation

- 4. Mantle cell lymphoma:

-- a) Failed or ineligible for autologous transplant AND a lymph node >= 2 cm at the time of pre-transplant evaluation

- 5. Diffuse large B cell lymphomas, large B cell transformation of an indolent lymphoma or other aggressive B cell lymphomas

-- a) Failed or ineligible for autologous transplant AND not in CR at the time of pre-transplant evaluation

- Confirmation of tumor diagnosis and expression of CD19 after review by University of Washington Medical Center (UWMC) or Seattle Cancer Care Alliance (SCCA) pathology services

- The patient has signed the informed consent form for this study

- DONOR: Genotypic or phenotypic HLA-identical family members

- DONOR: Express one or more of the following combinations of viral serostatus and HLA allele:

-- CMV seropositive and HLA-A*0101 positive

-- CMV seropositive and HLA-A*0201 positive

-- CMV seropositive and HLA-B*0702 positive

-- CMV seropositive and HLA-B*0801 positive

-- EBV seropositive and HLA-A*0201 positive

-- EBV seropositive and HLA-B*0801 positive

- DONOR: Hematocrit >= 35% at enrollment

- DONOR: Age >= 18 years

- DONOR: The donor has signed the informed consent form for the study

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Known central nervous system (CNS) tumor (CNS2 or CNS3) that is refractory to intrathecal chemotherapy and/or cranio-spinal radiation; patients with a history of CNS disease that has been effectively treated to CNS1 or lower evidence of disease will be eligible

- Human immunodeficiency virus (HIV) seropositive

- Significant medical or psychological conditions that would make them unsuitable candidates for T cell therapy

- Fertile patients unwilling to use contraception during and for 12 months after protocol enrollment

- Pregnant or breast-feeding

- DONOR: G-CSF administered within one month prior to the blood draw for T cell collection

- DONOR: Unable for any reason to provide a 400 ml blood draw

- DONOR: Inadequate peripheral veins for blood collection

- DONOR: HIV-1, HIV-2, human T-lymphotropic virus (HTLV)-1 or HTLV-2 seropositive

- DONOR: Active hepatitis B or hepatitis C virus infection

- DONOR: Positive serologic test for syphilis

- DONOR: Aberrant CD45RA isoform expression on all T cells

- DONOR: Systolic blood pressure (BP) < 80 or > 200

- DONOR: Heart rate < 50 or > 120, if considered due to cardiac disease

- DONOR: Oxygen (O2) saturation < 88% on room air

- DONOR: Serum creatinine (Cr) > 3.0

- DONOR: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 4 x the upper limit of normal

- DONOR: Unable to provide informed consent to participate

- DONOR: Significant medical conditions (e.g. immunosuppressive therapy) that would make them unsuitable T cell donors

- DONOR: Pregnant or nursing

Other exclusion criteria may apply.

Research Study Number       2494.00
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-288-1024

Hematologic Malignancies; Leukemia; Lymphoma; Non-Hodgkin's Lymphoma (NHL)

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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