Condition or disease | Intervention/treatment | Phase |
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Multiple Myeloma | Biological: CAR-T treatment | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | In this trial, T cells were seperated from refractory/relapsed multiple myeloma patients and engineered into BMCA-targeted CAR-T cells, and then transfused back into the patients for the treatment of their multiple myeloma. |
Masking: | None (Open Label) |
Masking Description: | It's an open-label trial. |
Primary Purpose: | Treatment |
Official Title: | B Cell Maturation Antigen(BMCA)-Targeted CAR-T for Refractory/Relapsed Multiple Myeloma |
Estimated Study Start Date : | July 31, 2019 |
Estimated Primary Completion Date : | November 30, 2022 |
Estimated Study Completion Date : | December 31, 2022 |
Arm | Intervention/treatment |
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Experimental: experiment group
In this arm, patients are treated with B Cell Maturation Antigen (BMCA)-targeted CAR-T cells and the safety and efficacy will be observed.
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Biological: CAR-T treatment
a novel method for treatment of multiple myeloma, in which patients' T cells are engineered into B Cell Maturation Antigen(BMCA)-Targeted CAR-T cells to eliminate myeloma cells.
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any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Wenbin Qian, MD,PhD | (+86)13605801032 | qianwenb@aliyun.com | |
Contact: Hui Liu, MD,PhD | (+86)13819198629 |
China, Zhejiang | |
The first affiliated hospital of Zhejiang University | Recruiting |
Hangzhou, Zhejiang, China, 310000 | |
Contact: Wenbin Qian, MD,PhD (+86)13605801032 qianwenb@aliyun.com |
Tracking Information | |||||||||
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First Submitted Date ICMJE | April 25, 2019 | ||||||||
First Posted Date ICMJE | April 30, 2019 | ||||||||
Last Update Posted Date | June 4, 2019 | ||||||||
Estimated Study Start Date ICMJE | July 31, 2019 | ||||||||
Estimated Primary Completion Date | November 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | B Cell Maturation Antigen(BMCA)-Targeted CAR-T for Refractory/Relapsed Multiple Myeloma | ||||||||
Official Title ICMJE | B Cell Maturation Antigen(BMCA)-Targeted CAR-T for Refractory/Relapsed Multiple Myeloma | ||||||||
Brief Summary | It's a single arm, open label prospective study, in which the safety and efficacy of B Cell Maturation Antigen(BMCA)-targeted CAR-T thearpy are evaluated in refractory/relapsed multiple myeloma patients. | ||||||||
Detailed Description | In this trial, T cells are seperated from multiple myeloma patients, and engineered into BMCA-targeted CAR-T cells, these cells are then transfused back into the patients to elimimnate the myeloma cells. In this process, the safety and efficacy of this CAR-T treatment are closely monitored. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: In this trial, T cells were seperated from refractory/relapsed multiple myeloma patients and engineered into BMCA-targeted CAR-T cells, and then transfused back into the patients for the treatment of their multiple myeloma. Masking: None (Open Label)Masking Description: It's an open-label trial. Primary Purpose: Treatment
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Condition ICMJE | Multiple Myeloma | ||||||||
Intervention ICMJE | Biological: CAR-T treatment
a novel method for treatment of multiple myeloma, in which patients' T cells are engineered into B Cell Maturation Antigen(BMCA)-Targeted CAR-T cells to eliminate myeloma cells.
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Study Arms ICMJE | Experimental: experiment group
In this arm, patients are treated with B Cell Maturation Antigen (BMCA)-targeted CAR-T cells and the safety and efficacy will be observed.
Intervention: Biological: CAR-T treatment
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
30 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 31, 2022 | ||||||||
Estimated Primary Completion Date | November 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03931421 | ||||||||
Other Study ID Numbers ICMJE | lymphoma center Q004 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Wenbin Qian, First Affiliated Hospital of Zhejiang University | ||||||||
Study Sponsor ICMJE | First Affiliated Hospital of Zhejiang University | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | First Affiliated Hospital of Zhejiang University | ||||||||
Verification Date | June 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |