Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma

This is a prospectiv , single arm, open-label, single-center study. This study is indicated for refractory and relapsed multiple myeloma. It aims to evaluate the safety and effectiveness of autologous hematopoietic stem cell transplantation combined with BCMA CAR-T to treat refractory and relapsed multiple myeloma. The main research is completely alleviated, overall reaction rate, and recurrence rate,etc. 50 patients will be enrolled.

Inclusion Criteria:

• 1、BCMA positive accompanied by refractory/relapsed and resistance;
• 2、Patients with the tumor load is high and cannot be transplanted directly, before transplantation. Reduce the load through CAR-T treatment to prepare for transplantation;
• 3、Patient relapses after transplantation,donor lymphocyte infusion Invalid. The donor cells in the recipient body can be used or the donor cells can be collected directly.Prepare CAR-T to prevent recurrence and induce relapsing;
• 4、Repeated MRD (+) refractory drug resistant cases;
• 5、Male or female, 30-75 years old;
• 6、Anticipated survival time more than 12 weeks
• 7、Transplant subjects, regardless of their previous treatment, are eligible for inclusion after relapse；
• 8、Patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up;
• 9、Those who voluntarily participate in the trial and sign the informed consent form

Exclusion Criteria:

• 1、Patients with the history of epilepsy or other CNS disease；
• 2、Patients with prolonged QT interval time or severe heart disease；
• 3、Pregnant or breastfeeding;
• 4、Active infection with no cure;
• 5、Patients with active hepatitis B or C infection;
• 6、Previously treated with any genetic therapy;
• 7、The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• 8、Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
• 9、Those who suffer from other uncontrolled diseases are not suitable to join the study;
• 10、HIV infection;
• 11、Any situation that the researchers believe may increase the risk of patients or interfere with the test results.