Clinical Study of CAR-BCMA T 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: NCT03716856|
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Refractory or Relapsed Multiple Myeloma||Genetic: CAR-BCMA T cells Drug: Fludarabine Drug: Cyclophosphamide||Phase 1|
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 change of T cell subsets relative to CAR-BCMA T。 (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 :||December 26, 2017|
|Estimated Primary Completion Date :||April 30, 2019|
|Estimated Study Completion Date :||August 31, 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
- Safety and effectivity - Incidence of study related adverse events [ Time Frame: 24 weeks ]Incidence of 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". After 24 hours of infusion, the CAR-BCMA DNA sequence was detected by PCR according to the follow-up time point, until the result of any two consecutive tests was negative and recorded as the "engraftment endpoint" of CAR-BCMA T cells.
- Statistical parameter of efficacy assessment：PFS [ Time Frame: 2 years ]Statistical parameter：Progression-free Survival (PFS)
- Statistical parameter of efficacy assessment：DCR [ Time Frame: 2 years ]Statistical parameter:Disease Control Rate (DCR)
- Statistical parameter of efficacy assessment：ORR [ Time Frame: 2 years ]Statistical parameter:Objective Remission Rate (ORR)
- Statistical parameter of efficacy assessment：OS [ Time Frame: 2 years ]Statistical parameter:Overall survival (OS)
- Number of RNA copies of CAR-BCMA T cells in tissue samples [ Time Frame: 2 years ]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.
- Positive incidence of anti-drug antibody [ Time Frame: 2 years ]Positive incidence of anti-BCMA anti-drug antibody (ADA).
- Change of T cell subsets from baseline counts [ Time Frame: 2 years ]Change of T cell subsets from baseline counts after infusion(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): NCT03716856
|Contact: Jie Jin, MDfirstname.lastname@example.org|
|Contact: Haitao Meng, MDemail@example.com|
|First Affiliated Hospital of Zhejiang University||Recruiting|
|Hangzhou, Zhejiang, China, 310006,|
|Contact: Jin Jie, MD +86-0571-87236896 firstname.lastname@example.org|
|Contact: Haitao Meng, MD +86-0571-87236896 email@example.com|
|Principal Investigator:||Jie Jin, MD||First Affiliated Hospital of Zhejiang University|
|Principal Investigator:||Haitao Meng, MD||First Affiliated Hospital of Zhejiang University|