| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 |
|---|---|
|
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.
|
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.
|
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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 |
|
||||||||
| 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 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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