BCMA+Multiple Myeloma
Conditions
Interventions
single arm:CD19/BCMA CAR-T therapy
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The patients must meet the following criteria for inclusion in the study: 1) Male or female, over the age of 18 2) Patients with refractory/recurrent MM diagnosed as BCMA positive; 3) Refractory/recurrent is defined as: a) Multiple myeloma has been adequately treated with at least one regimen containing proteasome inhibitors (PI) and/or immunoregulatory agents (IMiD) (induction therapy with or without hematopoietic stem cell transplantation and maintenance therapy is considered the same regimen. That is: induction chemotherapy, stem cell transplantation and maintenance therapy, if there is no disease progression, then it is considered as a treatment regimen. At least 1 full cycle of treatment per regimen, unless the optimal response is disease progression (PD) or below. Or progression or recurrence during or after the most recent anticancer treatment. b) The definition of disease progression and recurrence refer to the 2017 revision of Chinese guidelines for diagnosis and treatment of multiple myeloma. 4)ECOG = 3 months; 6)The absolute count of neutrophils is more than 0.5 x 10^9/L. 7)Platelet count >= 30 x 10^9 / L 8)Adequate organ function reserve: a)Glutamate transaminase/glutamate transaminase = 30mL/min; c)Serum total bilirubin = 50% by transechocardiography and no pericardial effusion or clinically significant ecg abnormalities were observed. e)Indoor natural air environment, the basic oxygen saturation > 92%. 9) The venous access needed for collection can be established, and there is no contraindication for white blood cell collection. 10) Women of childbearing age who failed a urine pregnancy test during the screening period and before starting the drug and who agreed to use effective contraception at least 100 days after the infusion; Male subjects whose partners are fertile must agree to use effective barrier contraception for at least 100 days after the infusion. 11) Sign informed consent.
Exclusion criteria
Exclusion criteria: Any of the following points are used as the exclusion criteria for patients: 1)Patients with other invasive malignant tumors (malignant tumors that have received radical treatment, no known active diseases within >= 3 years before enrollment, or non-melanoma skin cancer, in-situ cervical cancer, bladder cancer, breast cancer and other diseases that have been fully treated without any evidence of disease); 2)Severe mental disorders; 3)Any issues that are not conducive to subjects receiving or tolerating planned treatment or understanding informed consent in the study center, or any condition in which participating in the study is not considered by the investigator to be in the best interest of the subjects (for example, to the detriment of health), or any condition that may prevent, limit or confuse the study protocol assessment; 4)Known active central nervous system involvement or multiple myeloma meningeal involvement clinical signs; 5)Patients with grade iii-iv heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina or other clinically significant heart disease within 6 months prior to enrollment; 6)History or existence of the central nervous system diseases such as epilepsy disease, cerebral ischemia/hemorrhage, dementia, cerebellum, disease, or any kind of autoimmune disease involving CNS; 7) Any of the following test results is positive: HIV; HCV. HBV DNA copy number; TPPA. 8)There are other serious active viruses, bacteria infections or uncontrolled systemic fungal infection, active autoimmune diseases or autoimmune disease inside 3 years; 9)There are other serious active viruses, bacteria infections or uncontrolled systemic fungal infection, active autoimmune diseases or autoimmune disease inside 3 years; 10)Once or patients with interstitial lung disease (such as pneumonia, pulmonary fibrosis); 11)Due to factors such as physical, family, society, geography to adherence is poor, cannot do research plan and follow-up planners; 12)Patients contraindicated with cyclophosphamide or fludarabine chemotherapy; 13)Major surgery was performed within 2 weeks before the operation, or surgery was planned during the study period or within 2 weeks after the treatment (except for patients planning local anesthesia surgery); 14)Subjects requiring systemic corticosteroid therapy ( >= 5mg/ d prednisone or equivalent dose of other corticosteroids) or other immunosuppressive drugs within 28 days after CART return, except for adverse events during the trial; 15 Any other conditions that the researchers considered inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade of Toxicities and Adverse Events;overall response rate; | — |
Countries
China
Contacts
Public ContactGe Jian
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed