- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04272151
Safety and Efficacy of BCMA-Targeted CAR-T Therapy for Relapsed/Refractory Multiple Myeloma
April 16, 2023 updated by: Chongqing Precision Biotech Co., Ltd
This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
There are limited options for treatment of relapse/refractory Multiple Myeloma.
BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T.
In this study, investigators will evaluate the safety and efficacy of CAR-T targeting BCMA in patients with relapsed/refractory Multiple Myeloma.
The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Chongqing
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Chongqing, Chongqing, China
- Recruiting
- Chongqing University Cancer Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Signed written informed consent
Diagnose as relapsed /refractory multiple myeloma, and meet one of the following conditions:
- Failed to standard chemotherapy regimens;
- Relapse after complete remission, high-risk and / or refractory patients ;
- Relapse after hematopoietic stem cell transplantation;
- Evidence for cell membrane BCMA expression;
- All genders, ages: 18 to 75 years;
- The expect time of survive is above 12 weeks;
- KPS>60;
- No serious mental disorders ;
- Left ventricular ejection fraction ≥50%
- Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
- Sufficient renal function defined by creatinine clearance≤2 x ULN;
- Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
- With single or venous blood collection standards, and no other cell collection contraindications;
- Ability and willingness to adhere to the study visit schedule and all protocol requirements.
Exclusion Criteria:
- Have received CAR-T therapy or other genetically modified cell therapy before screening;
- Participated in other clinical research within 1 month before screening;
- Have received the following anti-tumor treatment before screening: Have received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except those who have confirmed disease progression after treatment;
- Live attenuated vaccine within 4 weeks before screening;
- Convulsion or stoke within past 6 months;
- Previous history of other malignancy;
- Presence of uncontrolled active infection;
- Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA titer is higher than the lower limit of detection of the research institution; HIV antibody positive; syphilis primary screening antibody positive;
- Pregnant or breasting-feeding women;
- Any situation that investigators regard not suitable for attending in this study or may affect the data analysis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BCMA CAR-T cells treat
Patients will be be treated with BCMA CAR-T cells
|
A single infusion of BCMA CAR-T cells will be administered intravenously.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events that related to treatment
Time Frame: 2 years
|
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
|
2 years
|
The response rate of BCMA CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA CAR-T cells therapy
Time Frame: 6 months
|
The response rate of BCMA CAR-T treatment will be recorded and assessed according to the IMWG
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levels of IL-6 in Serum
Time Frame: 3 months
|
In vivo (Serum) quantity of IL-6
|
3 months
|
Rate of BCMA CAR-T cells in bone marrow and peripheral blood
Time Frame: 2 years
|
In vivo (bone marrow and peripheral blood) rate of BCMA CAR-T cells were determined by means of flow cytometry
|
2 years
|
Quantity of BCMA CAR copies in bone marrow and peripheral blood
Time Frame: 2 years
|
In vivo (bone marrow and peripheral blood) quantity of BCMA CAR copies were determined by means of qPCR
|
2 years
|
Quantity of clonal plasma cells in bone marrow
Time Frame: 1 years
|
In vivo (bone marrow) quantity of clonal plasma cells
|
1 years
|
Duration of Response (DOR) of BCMA CAR-T treatment in patients with refractory/relapsed Multiple Myeloma
Time Frame: 2 years
|
DOR will be assessed from the first assessment of sCR/CR/VGPR/PR to the first assessment of recurrence or progression of the disease or death from any cause (censored)
|
2 years
|
Progress-free survival(PFS) of BCMA CAR-T treatment in patients with refractory/relapsed multiple myeloma
Time Frame: 2 years
|
PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression (censored)
|
2 years
|
Overall survival(OS) of BCMA CAR-T treatment in patients with refractory/relapsed multiple myeloma
Time Frame: 2 years
|
OS will be assessed from the first CAR-T cell infusion to death from any cause (censored)
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2019
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
July 1, 2024
Study Registration Dates
First Submitted
February 13, 2020
First Submitted That Met QC Criteria
February 14, 2020
First Posted (Actual)
February 17, 2020
Study Record Updates
Last Update Posted (Actual)
April 18, 2023
Last Update Submitted That Met QC Criteria
April 16, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- PBC015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
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Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
-
National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
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Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on BCMA CAR-T cells
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Zhejiang UniversityYake Biotechnology Ltd.RecruitingMultiple Myeloma | New Diagnosis TumorChina
-
University College, LondonEnrolling by invitationMultiple MyelomaUnited Kingdom
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Zhejiang UniversityYake Biotechnology Ltd.RecruitingRefractory Multiple Myeloma | Relapse Multiple MyelomaChina
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Zhejiang UniversityYake Biotechnology Ltd.RecruitingVasculitis | Amyloidosis | Autoimmune Hemolytic Anemia | POEMS SyndromeChina
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Southwest Hospital, ChinaUnknownLymphoma | Leukemia | Multiple MyelomaChina
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Zhejiang UniversityYake Biotechnology Ltd.Not yet recruitingRefractory Multiple Myeloma | Relapse Multiple MyelomaChina
-
Shenzhen University General HospitalRecruitingMultiple Myeloma | Refractory Multiple Myeloma | Relapse Multiple MyelomaChina
-
Chongqing Precision Biotech Co., LtdRecruitingMultiple Myeloma | Multiple Myeloma in Relapse | Neoplasm, Plasma CellChina
-
The First Affiliated Hospital of Nanchang UniversityUnknownRelapsed or Refractory Multiple MyelomaChina
-
Hrain Biotechnology Co., Ltd.First Affiliated Hospital of Wenzhou Medical University; Shanghai Changzheng...Recruiting