Back to resultsBCMA-CAR-T in Relapsed/Refractory Multiple Myeloma
Primary Purpose
Relapsed/Refractory Myeloma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
BCMA nanobody CAR-T cells
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed/Refractory Myeloma
Eligibility Criteria
Inclusion Criteria:
18 and ≤70 years old and the expected lifetime >3 months
- Active myeloma according to IMWG criteria, and BCMA positive by immunohistochemistry or flow cytometry
- No effective treatment option available
- ECOG score 0-2
- Sufficient heart, liver, kidney function (heart: no heart disease or coronary heart disease, patient heart function NYHA grade 1-2; liver: TBIL ≤ 3ULN, AST ≤ 2.5ULN, ALT ≤ 2.5ULN; kidney: Cr≤ 1.25ULN);
- smoothly peripheral superficial veins
- No other serious diseases that conflict with this protocol (eg, autoimmune diseases, immunodeficiency, organ transplantation)
- No history of other malignancies
- Women of childbearing age must be negative for blood pregnancy test within 7 days and must take appropriated contraceptive measures during and 3 months after the study
- The patient himself agrees to participate in this clinical study and signed the "informed consent"
Exclusion Criteria:
- Severe infectious 4 weeks before enrollment
- Active hepatitis B or C viral hepatitis, HIV,
- Severe autoimmune disease or immunodeficiency disease
- Severe allergies
- Severe mental disorder
- Patients who used high-dose glucocorticoids within 1 week
- Participation in other clinical studies in the past 3 months or having been treated with other gene products
Sites / Locations
- Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental group
Arm Description
BCMA nanobody CAR-T cells
Outcomes
Primary Outcome Measures
occurrence of study related adverse events
safety of CAR-T cells
Secondary Outcome Measures
Treatment response rate
response rate according to IMWG criteria
copy number of CAR-T cells
copy number of CAR-T cells
Full Information
NCT ID
NCT03664661
First Posted
September 6, 2018
Last Updated
September 7, 2018
Sponsor
Henan Cancer Hospital
Collaborators
The Pregene (ShenZhen) Biotechnology Company, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03664661
Brief Title
BCMA-CAR-T in Relapsed/Refractory Multiple Myeloma
Official Title
a Single-center, One Arm, Open Clinical Study of BCMA Nanobody CAR-T Cell in Refractory/Relapsed Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 11, 2018 (Actual)
Primary Completion Date
April 10, 2019 (Anticipated)
Study Completion Date
April 30, 2020 (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
Evaluation of the safety and efficacy of BCMA nanobody CAR-T cells in relapsed/refractory myeloma
Detailed Description
There are no effective regimens for relapsed/refractory myeloma. BCMA express extensively in mature B cells and plasma cells. Myeloma cells express BCMA universally. BCMA signal pathway can induce plasma cell proliferation and survival, down-regulation of BCMA could control the progression of myeloma. The BCMA CAR used in this study consists of BCMA nanobody, CD8 hinge, transmembrane region and 4-1bb co-stimulation domain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
BCMA nanobody CAR-T cells
Intervention Type
Drug
Intervention Name(s)
BCMA nanobody CAR-T cells
Intervention Description
step 1: Collect 50-100ml of peripheral blood for culture of BCMA nanobody CAR- T cells. step 2. After 72 hours, pretreated with FC regimen, details as follow Cyclophosphamide 600-800mg/m2 for 2 days Fludarabine 25-30mg/m2 for 3 days. step 3: After another 48 hours transfusion the cells back to the patients the numbers of infused CAR T cells are 5x106 /kg for the first 3 patients, 1.5x107 /kg for the second 3 patients and 4.5x107 /kg for the third 3 patients.
After finishing this, another 6 patients will be enrolled for observation of efficacy.
Primary Outcome Measure Information:
Title
occurrence of study related adverse events
Description
safety of CAR-T cells
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Treatment response rate
Description
response rate according to IMWG criteria
Time Frame
3 months and 6 months
Title
copy number of CAR-T cells
Description
copy number of CAR-T cells
Time Frame
one 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:
18 and ≤70 years old and the expected lifetime >3 months
Active myeloma according to IMWG criteria, and BCMA positive by immunohistochemistry or flow cytometry
No effective treatment option available
ECOG score 0-2
Sufficient heart, liver, kidney function (heart: no heart disease or coronary heart disease, patient heart function NYHA grade 1-2; liver: TBIL ≤ 3ULN, AST ≤ 2.5ULN, ALT ≤ 2.5ULN; kidney: Cr≤ 1.25ULN);
smoothly peripheral superficial veins
No other serious diseases that conflict with this protocol (eg, autoimmune diseases, immunodeficiency, organ transplantation)
No history of other malignancies
Women of childbearing age must be negative for blood pregnancy test within 7 days and must take appropriated contraceptive measures during and 3 months after the study
The patient himself agrees to participate in this clinical study and signed the "informed consent"
Exclusion Criteria:
Severe infectious 4 weeks before enrollment
Active hepatitis B or C viral hepatitis, HIV,
Severe autoimmune disease or immunodeficiency disease
Severe allergies
Severe mental disorder
Patients who used high-dose glucocorticoids within 1 week
Participation in other clinical studies in the past 3 months or having been treated with other gene products
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongping Song, M.D
Phone
+86-371-65587199
Email
songyongping2018@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Quanli Gao, M.D
Phone
+86-15038171966
Email
gaoquanli2015@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongping Song, M.D
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
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
BCMA-CAR-T in Relapsed/Refractory Multiple Myeloma
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