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Trial Title:
A Study of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
NCT ID:
NCT05712083
Condition:
Multiple Myeloma
New Diagnosis Tumor
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
BCMA CAR-T
Multiple Myeloma
New Diagnosis
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BCMA CAR-T cells
Description:
Each subject receive BCMA CAR T-cells by intravenous infusion
Arm group label:
Treatment Group
Other name:
BCMA CAR-T cells injection
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
Criteria for 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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital, College of Medicine, Zhejiang University
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
He Huang, MD
Phone:
86-13605714822
Email:
hehuangyu@126.com
Contact backup:
Last name:
Mingming Zhang, MD
Phone:
13656674208
Email:
mingmingzhang@zju.edu.cn
Start date:
January 30, 2023
Completion date:
April 1, 2024
Lead sponsor:
Agency:
Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Yake Biotechnology Ltd.
Agency class:
Industry
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05712083
