Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to infuse BCMA CAR-NK 92 cells to the patients with relapsed and refractory multiple myeloma (MM), to assess the safety and feasibility of this strategy. The CAR enables the NK-92 cells to recognize and kill the MM cells by targeting of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 multiple-myeloma
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 5, 2019
CompletedFirst Posted
Study publicly available on registry
May 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedMay 7, 2019
May 1, 2019
2 years
May 5, 2019
May 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence of treatment related adverse events as assessed by CTCAE v4.03
Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.
1 year
Study Arms (1)
anti-tumor response of BCMA CAR-NK-92
EXPERIMENTALPatients with relapsed and refractory MM of BCMA expression will be treated with BCMA CAR-NK 92 cells.
Interventions
The subject will be observed for any side effects during this time and all the adverse events will be recorded.
Eligibility Criteria
You may qualify if:
- years to 80 years, expected survival \> 3 months
- Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry
- BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease
- ECOG performance status of 0 - 1
- Cardiac function: 1 - 2 levels; Liver: TBIL ≤ 3ULN，AST ≤ 2.5 ULN，ALT ≤ 2.5ULN; kidney: Cr ≤ 1.25ULN
- No serious allergic constitution
- No other serous diseases that conflicts with the clinical program
- No other cancer history
- Female participants of reproductive potential must have a negative serum pregnancy test
- Subjects must have signed written, informed consent
You may not qualify if:
- Pregnant or lactating women
- Uncontrolled active infection, HIV infection, syphilis serology reaction positive
- Active hepatitis B or hepatitis C infection
- Recent or current use of glucocorticoid or other immunosuppressor
- Serious mental disorder
- With severe cardiac, liver, renal insufficiency, diabetes and other diseases
- Participate in other clinical research in the past three months
- Previously treatment with any gene therapy products
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Hematology, Wuxi People's Hospital, Nanjing Medical University
Wuxi, Jiangsu, 214000, China
Related Publications (1)
Ng YY, Du Z, Zhang X, Chng WJ, Wang S. CXCR4 and anti-BCMA CAR co-modified natural killer cells suppress multiple myeloma progression in a xenograft mouse model. Cancer Gene Ther. 2022 May;29(5):475-483. doi: 10.1038/s41417-021-00365-x. Epub 2021 Sep 1.
PMID: 34471234DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2019
First Posted
May 7, 2019
Study Start
May 1, 2019
Primary Completion
May 1, 2021
Study Completion
May 1, 2022
Last Updated
May 7, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share