Treatment of Chemotherapy Refractory Multiple Myeloma by CART-138 (CART-138)
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|ClinicalTrials.gov Identifier: NCT01886976|
Recruitment Status : Unknown
Verified January 2016 by Han weidong, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : June 26, 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 CD138 positive multiple myeloma that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Biological: CART-138 cells||Phase 1 Phase 2|
I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD138 vector (referred to as CART-138 cells).
II. Determine duration of in vivo survival of CART-138 cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood and bone marrow will be used to detect and quantify survival of CART-138 TCR zeta:CD137 and TCR (T-cell receptor) zeta cells over time.
I. For patients with detectable disease, measure anti-myeloma response due to CART-138 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-138 TCR zeta:CD137 and TCR zeta cells over time.
III. Estimate relative trafficking of CART-138 cells in bone marrow.
IV. For patients with stored or accessible myeloma cells, determine myeloma cell killing by CART-138 cells in vitro.
V. Determine if cellular or humoral host immunity develops against the murine anti-CD138, and assess correlation with loss of detectable CART-138 (loss of engraftment).
VI. Determine the relative subsets of CART-138 T cells (Tcm, Tem, and Treg).
OUTLINE: Patients are assigned to 1 group according to order of enrollment.
Patients receive anti-CD138-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)138 Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Multiple Myelomas|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2016|
Experimental: anti-CD138 CAR T cells
Patients receive anti-CD138-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: CART-138 cells
Other Name: chimeric antigen receptor T cells with specificity for CD138 genetically modified 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-myeloma responses to CART-138 cell infusions [ Time Frame: up to 24 weeks ]by measuring the changes of aberrant immunoglobulin in serum and multiple myeloma cells in bone marrow.
- in vivo existence of CART-138 [ Time Frame: 1 year ]measurement of CART-138 cells in peripheral blood by PCR method
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): NCT01886976
|Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Weidong Han, Ph.D 86-10-13651392893 email@example.com|
|Contact: Bo Guo, Ph.D 86-10-15201186743 firstname.lastname@example.org|
|Principal Investigator: Yao Wang, Ph.D|
|Principal Investigator: Quanshun Wang, Ph.D|