Genetically Engineered Lymphocyte Therapy in Treating Patients With Lymphoma That is Resistant or Refractory to Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01735604|
Recruitment Status : Recruiting
First Posted : November 28, 2012
Last Update Posted : September 29, 2015
RATIONALE: Placing a gene that has been created in the laboratory into white blood cells may make the body build an immune response to kill cancer cells.
PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with B-cell leukemia or lymphoma that is resistant or refractory to chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Hematopoietic/Lymphoid Cancer Adult Acute Lymphoblastic Leukemia in Remission B-cell Adult Acute Lymphoblastic Leukemia B-cell Chronic Lymphocytic Leukemia Prolymphocytic Leukemia Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Refractory Chronic Lymphocytic Leukemia Stage III Adult Diffuse Large Cell Lymphoma Stage III Chronic Lymphocytic Leukemia Stage III Grade 1 Follicular Lymphoma Stage III Grade 2 Follicular Lymphoma Stage III Grade 3 Follicular Lymphoma Stage III Mantle Cell Lymphoma Stage IV Adult Diffuse Large Cell Lymphoma Stage IV Chronic Lymphocytic Leukemia Stage IV Grade 1 Follicular Lymphoma Stage IV Grade 2 Follicular Lymphoma Stage IV Grade 3 Follicular Lymphoma Stage IV Mantle Cell Lymphoma||Biological: anti-CD20-CAR vector-transduced autologous T cells Other: genetically engineered lymphocyte therapy||Phase 1 Phase 2|
I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD20 vector (referred to as CART-20 cells).
II. Determine duration of in vivo survival of CART-20 cells. RT-PCR analysis of whole blood will be used to detect and quantify survival of CART-20 TCR zeta:4-1BB over time.
I. For patients with detectable disease, measure anti-tumor response due to CART-20 cell infusions.
II. Estimate relative trafficking of CART-20 cells to tumor in bone marrow and lymph nodes.
III. For patients with stored or accessible tumor cells (such as patients with active CLL, ALL, etc) determine tumor cell killing by CART-20 cells in vitro.
IV. Determine if cellular or humoral host immunity develops against the murine anti-CD20, and assess correlation with loss of detectable CART-20 (loss of engraftment).
V. Determine the relative subsets of CART-20 T cells (Tcm, Tem, and Treg).
OUTLINE: Patients are assigned groups according to order of enrollment.
Patients receive anti-CD20-CAR lentivirus vector-transduced autologous T cells with 41BB-gamma vector for 3-5 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 13 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Redirected Autologous T Cells Transduced to Express A CD20-Specific Chimeric Immunoreceptor in Patient With Chemotherapy Resistant or Refractory CD20+ Leukemia and Lymphoma|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||October 2018|
Experimental: anti-CD20-CAR T cell
Arm 1 Patients receive anti-CD20-CAR lentiviral vector-transduced autologous T cells with 41BB vector for 3-5 days in the absence of disease progression or unacceptable toxicity.
Biological: anti-CD20-CAR vector-transduced autologous T cells
anti-CD20-CAR vector-transduced autologous T cellsOther: genetically engineered lymphocyte therapy
genetically engineered lymphocyte therapy
- Occurrence of study related adverse events [ Time Frame: Until week 24 ]defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
- Anti-tumor responses to CART-20 cell infusions [ Time Frame: Baseline and post-infusion ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735604
|Contact: Han weidong, firstname.lastname@example.org|
|Contact: Bo jian, email@example.com|
|Biotherapeutic Department of Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Han weidong, Doctor +86-10-66937463 firstname.lastname@example.org|
|Contact: Bo jian, Doctor 86-10-13801257802 email@example.com|
|Principal Investigator: Han weidong, Doctor|
|Sub-Investigator: Bo Jian, Doctor|
|Sub-Investigator: Wang Yao, Master|