Safety and Efficacy of BCMA-Targeted CAR-T Therapy for Relapsed/Refractory Multiple Myeloma
NCT ID: NCT04272151
Last Updated: 2023-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2019-12-01
2024-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BCMA CAR-T cells treat
Patients will be be treated with BCMA CAR-T cells
BCMA CAR-T cells
A single infusion of BCMA CAR-T cells will be administered intravenously.
Interventions
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BCMA CAR-T cells
A single infusion of BCMA CAR-T cells will be administered intravenously.
Eligibility Criteria
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Inclusion Criteria
2. Diagnose as relapsed /refractory multiple myeloma, and meet one of the following conditions:
1. Failed to standard chemotherapy regimens;
2. Relapse after complete remission, high-risk and / or refractory patients ;
3. Relapse after hematopoietic stem cell transplantation;
3. Evidence for cell membrane BCMA expression；
4. All genders, ages: 18 to 75 years；
5. The expect time of survive is above 12 weeks;
6. KPS\>60；
7. No serious mental disorders ;
8. Left ventricular ejection fraction ≥50%
9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
10. Sufficient renal function defined by creatinine clearance≤2 x ULN;
11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
12. With single or venous blood collection standards, and no other cell collection contraindications;
13. Ability and willingness to adhere to the study visit schedule and all protocol requirements.
Exclusion Criteria
2. Participated in other clinical research within 1 month before screening；
3. 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;
4. Live attenuated vaccine within 4 weeks before screening;
5. Convulsion or stoke within past 6 months;
6. Previous history of other malignancy;
7. Presence of uncontrolled active infection;
8. 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;
9. Pregnant or breasting-feeding women;
10. Any situation that investigators regard not suitable for attending in this study or may affect the data analysis.
18 Years
75 Years
ALL
No
Sponsors
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Chongqing Precision Biotech Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Cheng Qian, PhD
Role: PRINCIPAL_INVESTIGATOR
Chongqing University Cancer Hospital
Ying Xiang, MD
Role: PRINCIPAL_INVESTIGATOR
Chongqing University Cancer Hospital
Locations
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Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PBC015
Identifier Type: -
Identifier Source: org_study_id
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