multiple myeloma
Conditions
Interventions
experimental group:umbilical cord blood-mediated CAR T (human targeted BCMA) cell immunotherapy
Sponsors
Shaanxi People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years old,Unlimited gender; 2. Signed informed consent (informed consent signed by the legal guardian of the child patient or the incapacitated person); 3. The estimated survival time is >= 3 months; 4. Indication:Patients with relapsed or refractory myeloma who must meet the Multiple Myeloma diagnostic criteria (2016) defined by the IMWG and meet the following conditions. Subjects have received sufficient prior treatment for at least 2 regimens (Note: Induction chemotherapy, stem cell transplantation, and maintenance therapy (if no disease progression occurs in between), it is considered as 1 regimen); Progression of disease (PD) or recurrence during or after the last treatment (according to the 2016 IMWG criteria); 5. Flow cytometry or immunohistochemical detection of bone marrow or plasmacytoma specimens, and BCMA expression could be detected on plasma cells; 6. Subjects must have measurable disease, including at least one of the criteria below: 1) Bone marrow blast or monoclonal plasma cells >= 5% of total bone marrow cells (Bone marrow cytometry, biopsies IHC or flow cytometry). 2) Serum M-protein >=10 g/L; 3) Urine M-protein >=200 mg/24 h; 4) FLC (Free Light Chain) type multiple myeloma with no other measurable disease detected in serum and urine: serum FLC>=10 mg/dL and Serum FLC kapa/gama ratio is abnormal; 5) Largest transverse diameter of extramedullary disease >=1 cm; 7. Organ function: Cardiac function: left ventricular ejection fraction > 40% in the last month (echocardiography) Liver function: cereal third transaminase and cereal grass transaminase 92%; 8. Drug usage: No systemic chemotherapy within 1 month. No other immunotherapy within 3 month. 9. Women of childbearing age must test for a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraception during and within 3 months of the trial (women who have undergone sterilization or who have been postmenopausal for at least 2 years are considered infertile); 10. Cerebrospinal fluid and brain magnetic resonance examination confirmed: no invasion of the central nervous system.
Exclusion criteria
Exclusion criteria: 1. Also suffering from other malignant tumors of viscera (those needing treatment); 2. Active heart diseases: A history of uncontrolled or symptomatic angina; Myocardial infarction less than 6 months before enrollment; A history of arrhythmias requiring medical treatment or with severe clinical symptoms; Uncontrolled or symptomatic congestive psychological failure(>NYHA level 2); 3. Active injection,need two or more antibiotics for treatment; 4. AIDS patients or Patients with immunodeficiency from any cause; 5. Epilepsy, dementia or other psychiatric conditions requiring medication inability to understand or follow the study protocol; 6. Substance abuse,medical psychological or social status that may interfere with a subject's participation in the study or assessment of study results; 7. Pregnancy or lactation; 8. Subjects requiring systemic corticosteroid treatment (>= 5 mg / d of prednisone or equivalent corticosteroids) or other immunosuppressive drugs during the study period, except for the treatment of adverse events; 9. Participating in other intervention studies; 10. Previously received BCMA targeted cell therapy; 11. Male and female subjects who do not wish to take birth control measures within 6 months after completion of BCMA-CART administration from the date of signing the consent form; 12. The researchers concludes that the group was unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate;Duration of continuous remission;event-free survival;overall survival;overall response rate;Incidence and grade of cytokine release syndrome;Incidence and grade of CART relatedencephalopathy syndrome; | — |
Countries
China
Contacts
Public ContactYi Wang
Shaanxi People's Hospital
Outcome results
None listed