Spots Global Cancer Trial Database for Clinical Study of CAR-BCMA T Cells in Patients With Refractory or Relapsed Multiple Myeloma
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Trial Identification
Brief Title: Clinical Study of CAR-BCMA T Cells in Patients With Refractory or Relapsed Multiple Myeloma
Official Title: Clinical Study of Redirected Autologous T Cells With a BCMA-targeted Chimeric Antigen Receptor in Patients With Refractory or Relapsed Multiple Myeloma
Study ID: NCT03380039
Conditions
Study Description
Brief Summary: A single arm, open-label pilot study is designed to determine the safety, efficacy and cytokinetics of CAR-BCMA T cells in patients with BCMA-positive refractory or relapsed multiple myeloma.
Detailed Description: This study is designed to determine the safety, tolerability and engraftment potential of anti-BCMA lentivirus-transduced autologous T cells in patients with refractory or relapsed multiple myeloma. Primary objectives: 1. Determine the safety and tolerability of CAR-BCMA T cells (autologous T cells transduced with chimeric antigen receptors recognizing BCMA) in patients with refractory or relapsed multiple myeloma. 2. Observe the cytokinetics of CAR-BCMA T cells. Secondary objectives: 1. Observe the anti-tumor response of CAR-BCMA T cells to refractory or relapsed multiple myeloma (evaluated by diagnostic criteria International Myeloma Working Group (IMWG2014 version) as CR, sCR, ICR, MCR or VGPR). 2. Make an evaluation on the distribution and in vivo survival of CAR-BCMA T cells in peripheral blood, lymph node, and bone marrow. 3. Observe the immunogenicity of CAR-BCMA T cells, and determine if there is anti-BCMA scFv cellular immune response and anti-BCMA scFv humoral immune response. 4. Observe the changes of cell subsets of CAR-BCMA T cells against T cells (Tcm, central memory T lymphocytes; Tem, effector memory T lymphocytes; Treg, regulatory T lymphocytes).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Xin Hua Hospital of Shanghai Jiao Tong University of Medicine, Shanghai, Shanghai, China
Contact Details
Name: Siguo Hao, MD
Affiliation: Xin Hua Hospital of Shanghai Jiao Tong University of Medicine
Role: PRINCIPAL_INVESTIGATOR
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