Treatment of Relapsed and/or Chemotherapy Refractory B-cell Malignancy by CART19 (CART19)
|ClinicalTrials.gov Identifier: NCT01864889|
Recruitment Status : Unknown
Verified January 2016 by Han weidong, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : May 30, 2013
Last Update Posted : January 28, 2016
RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build 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 relapsed (after stem cell transplantation or intensive chemotherapy) 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-CD19-CAR vector-transduced T cells||Not Applicable|
I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD19 (cluster of differentiation antigen 19 ) vector (referred to as CART-19 cells).
II. Determine duration of in vivo survival of CART-19 cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood will be used to detect and quantify survival of CART-19 TCR (T-cell receptor) zeta:CD137 and TCR zeta cells over time.
I. For patients with detectable disease, measure anti-tumor response due to CART-19 cell infusions.
II. To determine if the CD137 transgene is superior to the TCR zeta only transgene as measured by the relative engraftment levels of CART-19 TCR zeta:CD137 and TCR zeta cells over time.
III. Estimate relative trafficking of CART-19 cells to tumor in bone marrow and lymph nodes.
IV. For patients with stored or accessible tumor cells (such as patients with active chronic lymphocytic leukemia(CLL), acute lymphocytic leukemia (ALL), etc) determine tumor cell killing by CART-19 cells in vitro.
V. Determine if cellular or humoral host immunity develops against the murine anti-CD19, and assess correlation with loss of detectable CART-19 (loss of engraftment).
VI. Determine the relative subsets of CART-19 T cells (Tcm, Tem, and Treg).
OUTLINE: Patients are assigned to 1 group according to order of enrollment.
Patients receive anti-CD19-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells on days 0,1, and 2 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 :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Chimeric CD(Cluster of Differentiation)19 Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory B-cell Leukemias and Lymphomas|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||April 2017|
Experimental: anti-CD19 CAR T cells
Patients receive anti-CD19-CAR retroviral vector-transduced autologous or donor-derived T cells on days 0,1, 2 in the absence of disease progression or unacceptable toxicity.
Biological: anti-CD19-CAR vector-transduced T cells
genetically engineered lymphocyte therapy
Other Name: 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-19 cell infusions [ Time Frame: up to 24 weeks ]
- in vivo existence of CART19 [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864889
|Contact: weidong han, Dr.||firstname.lastname@example.org|
|Contact: ying liu, Dr.||email@example.com|
|Biotherapeutic Department and Pediatrics Department of Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Weidong Han, Dr. 86-10-66937463 firstname.lastname@example.org|
|Contact: Ying Liu, Dr. 86-1-13910392619 email@example.com|
|Sub-Investigator: Yao Wang, Dr.|