- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03664661
BCMA-CAR-T in Relapsed/Refractory Multiple Myeloma
a Single-center, One Arm, Open Clinical Study of BCMA Nanobody CAR-T Cell in Refractory/Relapsed Myeloma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450000
- Recruiting
- Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital
-
Contact:
- Yongping Song
- Phone Number: +86-13521186987
- Email: ph200811@163.com
-
Principal Investigator:
- Yongping Song
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: experimental group
BCMA nanobody CAR-T cells
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
occurrence of study related adverse events
Time Frame: 4 weeks
|
safety of CAR-T cells
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment response rate
Time Frame: 3 months and 6 months
|
response rate according to IMWG criteria
|
3 months and 6 months
|
copy number of CAR-T cells
Time Frame: one year
|
copy number of CAR-T cells
|
one year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- HenanCH CAR 2-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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