Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
15 participants
INTERVENTIONAL
2018-04-11
2020-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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SEQUENTIAL
TREATMENT
NONE
Study Groups
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experimental group
BCMA nanobody CAR-T cells
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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The Pregene (ShenZhen) Biotechnology Company, Ltd.
INDUSTRY
Henan Cancer Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Yongping Song, M.D
Role: STUDY_CHAIR
Henan Cancer Hospital
Locations
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Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HenanCH CAR 2-2
Identifier Type: -
Identifier Source: org_study_id
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