Back to resultsStudy of BCMA CAR-T in Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Fludarabine
Cyclophosphamide
BCMA CAR-T
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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;
Sites / Locations
- Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
anti-tumor response of BCMA CAR-T
Arm Description
Drug: Cyclophosphamide patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days. Drug: Fludarabine Fludarabine 25-30mg/m2/day IV for 3 days. Biological: BCMA CAR-T BCMA CAR-T cells will be administered after completion of the chemotherapy.
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events
number of participants with adverse events
Secondary Outcome Measures
Persistence of the BCMA CAR+ T cells
determine duration of in vivo survival of BCMA CAR-T cells
anti-tumor responses of BCMA CAR-T cells
Full Information
NCT ID
NCT03322735
First Posted
October 19, 2017
Last Updated
December 28, 2017
Sponsor
Henan Cancer Hospital
Collaborators
The Pregene (ShenZhen) Biotechnology Company, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03322735
Brief Title
Study of BCMA CAR-T in Multiple Myeloma
Official Title
A Study of BCMA CAR-T Cells for Patients With Relapse and Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 8, 2017 (Actual)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Cancer Hospital
Collaborators
The Pregene (ShenZhen) Biotechnology Company, Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 T cell to recognize and kill the MM cells through the recognition of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anti-tumor response of BCMA CAR-T
Arm Type
Experimental
Arm Description
Drug: Cyclophosphamide patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days.
Drug: Fludarabine Fludarabine 25-30mg/m2/day IV for 3 days. Biological: BCMA CAR-T BCMA CAR-T cells will be administered after completion of the chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
25-30mg/m2/day IV for 3 days
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
cyclophosphamide 0.6-0.8g/m2/day IV for 2 days
Intervention Type
Biological
Intervention Name(s)
BCMA CAR-T
Intervention Description
BCMA CAR-T cells will be administered after completion of the chemotherapy.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
number of participants with adverse events
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Persistence of the BCMA CAR+ T cells
Description
determine duration of in vivo survival of BCMA CAR-T cells
Time Frame
1 year
Title
anti-tumor responses of BCMA CAR-T cells
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongping Song
Phone
+86-13521186987
Email
ph200811@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongping Song
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongping Song
Phone
+86-13521186987
Email
ph200811@163.com
First Name & Middle Initial & Last Name & Degree
Yongping Song
12. IPD Sharing Statement
Learn more about this trial
Study of BCMA CAR-T in Multiple Myeloma
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