Status:
UNKNOWN
Study of BCMA CAR-T in Multiple Myeloma
Lead Sponsor:
Henan Cancer Hospital
Collaborating Sponsors:
The Pregene (ShenZhen) Biotechnology Company, Ltd.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to infusion BCMA CAR-T cells to the patients with relapsed and refractory multiple myeloma(MM), to assess the safety and feasibility of this strategy. The CAR enables the ...
Eligibility Criteria
Inclusion
- 1\. 18 years to 70 years, expected survival \> 3 months;
- 2\. Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry.
- 3\. BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease.；
- 4\. ECOG performance status of 0-2;
- 5\. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN;
- 6\. No serious allergic constitution;
- 7\. No other serous diseases that conflicts with the clinical program;
- 8\. No other cancer history;
- 9\. female participants of reproductive potential must have a negative serum pregnancy test;
- 10\. Subjects must have signed written, informed consent.
Exclusion
- 1\. Pregnant or lactating women;
- 2\. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- 3\. Active hepatitis B or hepatitis C infection;
- 4\. Recent or current use of glucocorticoid or other immunosuppressor;
- 5\. serious mental disorder;
- 6\. With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
- 7\. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;
Key Trial Info
Start Date :
December 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03322735
Start Date
December 8 2017
End Date
December 1 2019
Last Update
December 29 2017
Active Locations (1)
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1
Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China