Multiple Myeloma
Conditions
Interventions
Experimental group:Combination infusion of hCD19 CAR-T cells and mBCMA CAR-T cells
Control group:Autologous hematopoietic stem cell transplantation
Sponsors
Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female participants aged >= 18 and 12 weeks. 3. Participants must have a confirmed diagnosis of multiple myeloma. 4. Patients do not achieve complete remission after being treated with 2-4 courses of bortezomib-included. chemotherapy . 5. ALT/AST = 50%). 8. No serious liver, kidney, heart and other diseases at the time of enrollment. 9. Be eligible for auto-hematopoietic stem cell transplantation (ASCT). 10. Voluntarily participated in the trial of CAR-T for the treatment of multiple myeloma. 11. Blood was collected intravenously and no other contraindications for aphresis. 12. Informed Consent/Assent: All subjects have the ability to understand and the willingness to sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, or female with a pregnancy plan within six months; 2. Infectious diseases (eg HIV, active tuberculosis, etc.); 3. Active hepatitis B or hepatitis C; 4. Evaluation screening showed that the transfected lymphocytes was less than 10% or proliferation< 5 times under the co-stimulation of CD3/CD28; 5. Abnormal vital signs and failure to cooperate with the examination; 6. Any mental or psychological illnesses that could, in the investigator's opinion, potentially interfere with the completion of treatment; 7. Highly allergic constitution or history of severe allergies, especially to IL-2; 8. Systemic or severe local infections require anti-infective treatment; 9. Evidence of current uncontrolled dysfunction of heart, lung, brain, kidney and other important organs; 10. Active and severe auto-immune disease; 11. Other conditions that are not eligible for the trial in the judgment of the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Countries
China
Contacts
Public ContactKailin Xu
Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed