CD19 CAR T Cells for B Cell Malignancies After Allogeneic Transplant

Completed · Phase 1/Phase 2

Conditions studied: Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia, Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma, Refractory Chronic Lymphocytic Leukemia

In brief

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.

Key facts

Study ID

NCT01475058

Run by

Fred Hutchinson Cancer Center

People needed

1

Starts

2012-04-01

Expected to finish

2014-07-01

Last updated by the study team

2017-02-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Philadelphia chromosome negative acute lymphoblastic leukemia:
• Beyond first complete remission (CR) at the time of pre-transplant evaluation
• Required > 1 cycle of induction chemotherapy to achieve CR
• 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)
• First CR with poor risk cytogenetics (t(4:11), t(8;14), hypodiploidy, near triploidy or > 5 cytogenetic abnormalities) at diagnosis
• Planned for or have had a reduced intensity conditioned or non-myeloablative transplant
• Philadelphia positive acute lymphoblastic leukemia
• Not in CR at the time of pre-transplant evaluation
• In CR with the following features:
• Intolerant or unwilling to use a TKI after HCT
• Current or previous detection of cytogenetic abnormalities in addition to t(9;22) by conventional karyotyping, FISH or molecular methods
• Chronic lymphocytic leukemia, or low grade B cell lymphomas:
• 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
• Mantle cell lymphoma:
• Failed or ineligible for autologous transplant AND a lymph node >= 2 cm at the time of pre-transplant evaluation
• Diffuse large B cell lymphomas, large B cell transformation of an indolent lymphoma or other aggressive B cell lymphomas
• 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

You may not qualify if…

• 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

Where it is running

• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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