A Study of Humanized BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma

Prior treatment

• Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
• Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;

Other illness

• History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
• Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
• Active infection of hepatitis B virus or hepatitis C virus;
• Other uncontrolled diseases that were not suitable for this trial;
• Patients with HIV infection;

Lab values

• Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
• Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;

Other

• Subjects with any of the following exclusion criteria were not eligible for this trial:
• Pregnant (or lactating) women;
• Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

• Histologically confirmed diagnosis of multiple myeloma (MM):
  • Patients with BCMA positive relapsed/refractory MM;
  • Relapsed after hematopoietic stem cell transplantation;
  • Cases with recurrent positive minimal residual disease;
  • Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
• Anticipated survival time more than 12 weeks;
• Male or female aged 30-75 years;
• Those who voluntarily participated in this trial and provided informed consent.