A Study of Humanized BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
NCT ID: NCT04670055
Last Updated: 2020-12-17
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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NOT_YET_RECRUITING
EARLY_PHASE1
50 participants
INTERVENTIONAL
2021-01-01
2027-01-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Administration of BCMA Targeted CAR T-cells
Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
BCMA Targeted CAR T-cells
Each subject receive BCMA Targeted CAR T-cells by intravenous infusion
Interventions
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BCMA Targeted CAR T-cells
Each subject receive BCMA Targeted CAR T-cells by intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Patients with BCMA positive relapsed/refractory MM;
2. Relapsed after hematopoietic stem cell transplantation;
3. Cases with recurrent positive minimal residual disease;
4. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
2. Anticipated survival time more than 12 weeks;
3. Male or female aged 30-75 years;
4. Those who voluntarily participated in this trial and provided informed consent.
Exclusion Criteria
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
5. Active infection of hepatitis B virus or hepatitis C virus;
6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
8. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
9. Other uncontrolled diseases that were not suitable for this trial;
10. Patients with HIV infection;
11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
30 Years
75 Years
ALL
No
Sponsors
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Yake Biotechnology Ltd.
INDUSTRY
Zhejiang University
OTHER
Responsible Party
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He Huang
Clinical Professor
Locations
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The First Affiliated Hospital, Medical College, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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He Huang, MD
Role: primary
References
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Chen R, Jin C, Liu K, Zhao M, Yang T, Zhang M, Xiao P, Feng J, Hong R, Fu S, Cui J, Huang S, Wei G, Huang H, Hu Y. Predictive value of pre-treatment circulating tumor DNA genomic landscape in patients with relapsed/refractory multiple myeloma undergoing anti-BCMA CAR-T therapy: Insights from tumor cells and T cells. Chin Med J (Engl). 2024 Nov 6;138(19):2481-90. doi: 10.1097/CM9.0000000000003306. Online ahead of print.
Other Identifiers
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hBCMA-ZhejiangU
Identifier Type: -
Identifier Source: org_study_id