Treatment of Relapsed and/or Chemotherapy Refractory CD33 Positive Acute Myeloid Leukemia by CART-33 (CART33)
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|ClinicalTrials.gov Identifier: NCT01864902|
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 to study genetically engineered lymphocyte therapy in treating patients with CD33 positive acute myeloid leukemias that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Relapsed Adult Myeloid Leukemia Chemotherapy Refractory Adult Myeloid Leukemia||Biological: CART33 cells Biological: anti-CD33 CART Biological: anti-CD33 CAR T cells||Phase 1 Phase 2|
I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD33 vector (referred to as CART-33 cells).
II. Determine duration of in vivo survival of CART-33 cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood will be used to detect and quantify survival of CART-33 TCR zeta:CD137 and TCR (T-cell receptor) zeta cells over time.
I. For patients with detectable disease, measure anti-leukemia response due to CART-33 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-33 TCR zeta:CD137 and TCR zeta cells over time.
III. Estimate relative trafficking of CART-33 cells in bone marrow.
IV. For patients with stored or accessible leukemia blasts, determine leukemia cell killing by CART-33 cells in vitro.
V. Determine if cellular or humoral host immunity develops against the murine anti-CD33, and assess correlation with loss of detectable CART-33 (loss of engraftment).
VI. Determine the relative subsets of CART-33 T cells (Tcm, Tem, and Treg).
OUTLINE: Patients are assigned to 1 group according to order of enrollment.
Patients receive anti-CD33-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 :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Chimeric CD(Cluster of Differentiation)33 Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Acute Myeloid Leukemias|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2017|
Experimental: anti-CD33 CAR T cells
Patients receive anti-CD33-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: CART33 cells
genetically modified lymphocyte therapy
Other Name: chimeric antigen receptor T cells with specificity for CD33
Biological: anti-CD33 CART
Other Name: CART33
Biological: anti-CD33 CAR T cells
- 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-leukemia responses to CART-33 cell infusions [ Time Frame: up to 24 weeks ]
- in vivo existence of CART33 [ 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): NCT01864902
|Contact: Weidong Han, Dr.||firstname.lastname@example.org|
|Contact: Xuliang Shen, Dr.||email@example.com|
|Biotherapeutic Department and Pediatrics Department of Chinese PLA General Hospital, Hematological Department, Affiliated Hospital of Changzhi Medical College||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Weidong Han, Dr. 86-10-13651392893 firstname.lastname@example.org|
|Contact: Xuliang Shen, Dr. 86-355-13015365546 email@example.com|
|Sub-Investigator: Ying Liu, Dr.|
|Sub-Investigator: Yao Wang, Dr.|