Back to resultsA Study of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
Primary Purpose
Multiple Myeloma, New Diagnosis Tumor
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
BCMA CAR-T cells
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring BCMA CAR-T, Multiple Myeloma, New Diagnosis
Eligibility Criteria
Inclusion Criteria: 1.Age and gender unlimited; 2.According to the IMWG2014 standard, diagnosis as multiple myeloma; 3.According to the MSMART 3.0 standard, it is defined as a high-risk multiple myeloma; 4.Abnormal plasmocyte BCMA expression positive; 5.Echocardiography shows the left ventricular ejection score (LVEF) ≥50%; 6.The subject has no lung activity infection; 7.Expected life time is more than 3 months; 8.ECOG score 0-2 score; 9.Voluntarily participate in the trial and sign the informed consent form. Exclusion Criteria: 1.Patients with the history of epilepsy or other CNS disease; 2.Patients with prolonged QT interval time or severe heart disease; 3.Pregnant or breastfeeding; 4.Active infection with no cure; 5.Patients with active hepatitis B or C infection; 6.Previously treated with any genetic therapy; 7.The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; 8.Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl; 9.Those who suffer from other uncontrolled diseases are not suitable to join the study; 10.HIV infection; 11.Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Sites / Locations
- The First Affiliated Hospital, College of Medicine, Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
This is a single arm clinical trial.
Outcomes
Primary Outcome Measures
Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Secondary Outcome Measures
Multiple Myeloma (MM), Overall response rate (ORR)
Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR) at Month 6, 12, 18 and 24
Complete response rate(CRR)
Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)
Partial response Rate (PRR)
Proportion of subjects who achieved a partial response (PR)
Overall survival
Death from any cause from the beginning of cell transfusion
Full Information
NCT ID
NCT05712083
First Posted
January 31, 2023
Last Updated
February 17, 2023
Sponsor
Zhejiang University
Collaborators
Yake Biotechnology Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05712083
Brief Title
A Study of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
Official Title
Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
Collaborators
Yake Biotechnology Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
Detailed Description
This is a single arm, open-label, single-center study. This study is indicated for newly diagnosed multiple myeloma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 40 patients will be enrolled. Primary objective is to explore the safety and efficacy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, New Diagnosis Tumor
Keywords
BCMA CAR-T, Multiple Myeloma, New Diagnosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
This is a single arm clinical trial.
Intervention Type
Drug
Intervention Name(s)
BCMA CAR-T cells
Other Intervention Name(s)
BCMA CAR-T cells injection
Intervention Description
Each subject receive BCMA CAR T-cells by intravenous infusion
Primary Outcome Measure Information:
Title
Dose-limiting toxicity (DLT)
Description
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time Frame
Baseline up to 28 days after BCMA CAR T-cells infusion
Title
Incidence of treatment-emergent adverse events (TEAEs)
Description
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Time Frame
Baseline up to 2 years after BCMA CAR T-cells infusion
Secondary Outcome Measure Information:
Title
Multiple Myeloma (MM), Overall response rate (ORR)
Description
Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR) at Month 6, 12, 18 and 24
Time Frame
At Month 1, 3, 6, 12, 18 and 24
Title
Complete response rate(CRR)
Description
Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)
Time Frame
Baseline up to 2 years after BCMA CAR T-cells infusion
Title
Partial response Rate (PRR)
Description
Proportion of subjects who achieved a partial response (PR)
Time Frame
Up to 2 years after BCMA CAR T-cells infusion
Title
Overall survival
Description
Death from any cause from the beginning of cell transfusion
Time Frame
Up to 2 years after BCMA CAR T-cells infusion
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Age and gender unlimited;
2.According to the IMWG2014 standard, diagnosis as multiple myeloma;
3.According to the MSMART 3.0 standard, it is defined as a high-risk multiple myeloma;
4.Abnormal plasmocyte BCMA expression positive;
5.Echocardiography shows the left ventricular ejection score (LVEF) ≥50%;
6.The subject has no lung activity infection;
7.Expected life time is more than 3 months;
8.ECOG score 0-2 score;
9.Voluntarily participate in the trial and sign the informed consent form.
Exclusion Criteria:
1.Patients with the history of epilepsy or other CNS disease;
2.Patients with prolonged QT interval time or severe heart disease;
3.Pregnant or breastfeeding;
4.Active infection with no cure;
5.Patients with active hepatitis B or C infection;
6.Previously treated with any genetic therapy;
7.The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
8.Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
9.Those who suffer from other uncontrolled diseases are not suitable to join the study;
10.HIV infection;
11.Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
He Huang, MD
Phone
86-13605714822
Email
hehuangyu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mingming Zhang, MD
Phone
13656674208
Email
mingmingzhang@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
He Huang, MD
Organizational Affiliation
First Affiliated Hospital of Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital, College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He Huang, MD
Phone
86-13605714822
Email
hehuangyu@126.com
First Name & Middle Initial & Last Name & Degree
Mingming Zhang, MD
Phone
13656674208
Email
mingmingzhang@zju.edu.cn
12. IPD Sharing Statement
Learn more about this trial
A Study of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
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