plasma cell malignancies
Conditions
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age and gender: 18 years old = 12 weeks; 7) The subjects must have proper organ function and meet all the following laboratory test results before entering the group: a) Blood routine test: neutrophil >= 1.0 x 10^9 / L; hemoglobin >= 70 g / L; platelet >= 50 x 10^9 / L; b) Liver function: ALT and AST = 60 ml / min. d) Electrolyte: blood potassium >= 3.0 mmol / L; blood calcium >= 2.0 mmol / L; blood magnesium >= 0.5 mmol / L; e) Coagulation function: fibrinogen >= 1.0g/l; activated partial thromboplastin time (APTT) <= Keywords ULN + 10s; prothrombin time (PT) < ULN + 3S; 8) The subjects should be willing to provide effective diagnosis evidence or bone marrow examination before treatment, and bone marrow or effective examination after treatment; 9) Women of childbearing age and fertile male subjects must take one of the following effective contraceptive measures from signing informed consent until one year after ct103a cell transfusion: abstinence, double barrier contraceptive method, IUD, hormone contraceptive; 10) Male subjects were forbidden to donate sperm from signing the informed consent until one year after ct103a cell transfusion; 11) Sign informed consent a) The subject must have informed consent to the test before the test, and be voluntary by himself (or his legal representative) signed the written informed consent; b) The subjects or their legal representatives can communicate well with the researchers and follow the protocol complete the test.
Exclusion criteria
Exclusion criteria: 1) Previous treatment history a) Received hematopoietic stem cell transplantation within 2 months before the start of administration, or within the screening period After transplantation, immunosuppressive therapy was used because of graft-versus-host disease; b) Patients who had received chemotherapy, immunotherapy, radiotherapy and major surgery within 4 weeks before the start of administration; c) Those who received the live vaccine within 4 weeks before the start of administration and / or planned to receive the live vaccine after the trial; d) Those who have received clinical trial drug treatment or are participating in other clinical trials within 4 weeks before drug administration; 2) History of disease and operation a) Patients with central nervous system invasion by plasmacytoma; b) Hypertension and drug treatment can not get good control (blood pressure > 140 / 90 mmHg); c) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) = 2, or male QTc > 450 ms, female QTc > 470 MS (QTc was calculated by the friderica correction formula QTc = QT / rr0.33); patients with a history of tip torsion or congenital QT prolongation syndrome; e) Patients with any of the following diseases within 12 months before administration: myocardial infarction, severe or unstable heart, patients with colic, coronary artery bypass or peripheral artery bypass grafting, congestive heart failure, cerebrovascular events (including transient ischemic attack), etc; f) During the screening period, the researchers judged that there were uncontrollable and active infectious diseases; g) People infected with human immunodeficiency virus (HIV); h) HBsAg was positive and in the active phase of hepatitis B (HBV DNA quantity >= 1.00 x 10^2 copies / ml); i) Hepatitis C antibody (anti HCV) was positive and was in the active phase of hepatitis C (hepatitis C RNA was not in the normal mode)Perimetric value); j) The researchers judged patients with severe electrolyte disorder; k) Patients with a clear tendency of gastrointestinal bleeding, including the following: local active ulcer focus, and stool occult blood (>= + +); patients with a history of black stool and hematemesis within 2 months; researchers believe that digestion may occur Patients with massive bleeding of the Tao; l) Patients with a history of solid organ transplantation; m) The investigator or sponsor thinks that he / she has other acute, serious or chronic medical or psychological diseases and is not suitable for participation Add clinical trial; n) Pregnant and nursing women 3) Prohibited treatment and / or medication a) At the same time, other anti-tumor drugs, including traditional Chinese medicine, were used; b) At the same time, take drugs that can prolong QT interval (including class IA and III antiarrhythmic drugs); c) Those who need to receive oxygen every day; d) Long term use of corticosteroids (except for local inhalation); 4) others a) Those who have a history of psychoactive drug abuse and are unable to give up or have mental disorders; b) Habitually drink grapefruit juice or excessive tea, coffee and / or caffeinated beverages during the trial Unable to give up; c) According to the judgment of the researchers, there are serious concomitant diseases endangering the safety of patients or affecting the completion of the trialillnes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactJianfeng Zhou
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed