Clinical Study of CAR-BCMA T Cells in Patients With Refractory or Relapsed Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03380039|
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : December 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Refractory or Relapsed Multiple Myeloma||Genetic: CAR-BCMA T cells Drug: Fludarabine Drug: Cyclophosphamide||Not Applicable|
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.
- 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.
- Observe the cytokinetics of CAR-BCMA T cells.
- 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).
- Make an evaluation on the distribution and in vivo survival of CAR-BCMA T cells in peripheral blood, lymph node, and bone marrow.
- 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.
- 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Redirected Autologous T Cells With a BCMA-targeted Chimeric Antigen Receptor in Patients With Refractory or Relapsed Multiple Myeloma|
|Actual Study Start Date :||October 13, 2017|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2020|
Experimental: CAR-BCMA T cells
In this study, autologous T cells transduced with a BCMA-targeted chimeric antigen receptor (CAR-BCMA T cells) are used to treat patients with refractory or relapsed multiple myeloma.
Route of administration: Intravenous injection.
Lymphodepletion will be conducted several days prior to CAR-BCMA T cells infusion.
A combination of fludarabine and cyclophosphamide will be used for lymphodepletion.
Genetic: CAR-BCMA T cells
Single dose of CAR-BCMA T cells will be infused, and classic "3+3" dose escalation will be applied.
Other Name: BCMA-redirected autologous T cells
Fludarabine is used for lymphodepletion.
Cyclophosphamide is used for lymphodepletion.
- Number of participants with CAR-BCMA T cell therapy-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 24 weeks ]Number of participants with study related adverse events which are defined as laboratory toxicities and clinical events that are possible, likely or definitely related to study treatment at any time from the infusion until week 24, including infusion related toxicity and any toxicity possibly related to CAR-BCMA T cells.
- Engraftment [ Time Frame: 2 years ]Duration of in vivo survival of CAR-BCMA T cells is defined as "engraftment". The primary engraftment endpoint is the number of CAR-BCMA DNA vector copies per mL blood of CAR-BCMA T cells at regular intervals from 24 hours after initial infusion through 2 years of last infusion. PCR for CAR-BCMA T vector sequences will be performed until any 2 sequential tests are negative, documented as engraftment of CAR-BCMA T cells.
- Anti-tumor response of CAR-BCMA T cell infusion [ Time Frame: 2 years ]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).
- Number of RNA copies of CAR-BCMA T cells in tissue samples [ Time Frame: 2 years ]The number of RNA copies of CAR-BCMA T cells in lymph node samples or bone marrow samples at regular intervals from 24 hours after the initial infusion.
- Anti-drug antibody [ Time Frame: 2 years ]Detect titer of anti-BCMA anti-drug antibody (ADA).
- Changes of cell subsets of CAR-BCMA T cells against T cells [ Time Frame: 2 years ]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).
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): NCT03380039
|Contact: Siguo Hao, MDemail@example.com|
|Xin Hua Hospital of Shanghai Jiao Tong University of Medicine||Recruiting|
|Shanghai, Shanghai, China, 200092|
|Contact: Siguo Hao, MD +86-021-25077600 firstname.lastname@example.org|
|Principal Investigator: Siguo Hao, MD|
|Principal Investigator:||Siguo Hao, MD||Xin Hua Hospital of Shanghai Jiao Tong University of Medicine|