Plasma cell tumor
Conditions
Interventions
experimental group:anti-BCMA and anti-CD19 double targets CAR-T
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
5 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 5-70; 2. The patients' ECoG score is less than or equal to 2, and the estimated survival time is more than 12 weeks; 3. Patients diagnosed as refractory or recurrent plasmacytoma, including (1) Multiple myeloma, plasmacytic leukemia, poems syndrome, megaglobulinemia of Fahrenheit, extramedullary plasmacytoma, solitary plasmacytoma or primary amyloidosis of bone; (2) Lymphocytic diseases containing plasma cells, such as plasmocytic lymphoma and Castleman's disease. 4. Patients with measurable or evaluable lesions; 5. The function of main tissues and organs of the patient is good: (1) Liver function: ALT / AST = 95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) >= 40%. 6. Patients who are not suitable for hematopoietic stem cell transplantation or who give up transplantation or relapse after transplantation due to limited conditions; 7. Patients who can take blood from vein without other contraindications of leukocyte removal; 8. Patients or their legal guardians voluntarily participate in and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, or women who have pregnancy plans within half a year; 2. Patients with infectious diseases (such as HIV, active hepatitis B or C infection, active tuberculosis, etc.); 3. Feasibility evaluation and screening showed that the target lymphocyte was less than 10% transfected or less than 5 times amplified under the co stimulation of CD3 / CD28; 4. Patients whose vital signs are abnormal and who cannot cooperate with the examination; 5. Patients with mental or psychological diseases who can not cooperate with treatment and efficacy evaluation; 6. High allergic constitution or severe allergic history, especially for IL-2 allergy; 7. Subjects who need anti infection treatment for systemic infection or local severe infection; 8. Patients with dysfunction of heart, lung, brain, liver, kidney and other important organs; 9. Patients who cannot be included in the treatment for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of antibody;Overall response rate;Partial response;Stable disease;Progressive disease; | — |
Countries
China
Contacts
Public ContactJiang Cao
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed