Safety and Efficacy of APRIL-BAFF-Bicephali CAR-T in Relapsed, Refractory Multiple Myeloma

Más betegség

• Infectious diseases (such as HIV, active tuberculosis, etc.);
• Active hepatitis B or hepatitis C infection;
• Have mental or mental illness who cannot cooperate with the treatment and efficacy evaluation;
• Highly allergic constitution or have a history of severe allergies, especially allergic to IL-2;
• Subjects with a systemic infection or a severe local infection requiring anti-infective treatment;
• Subjects with severe autoimmune disease;

Laborértékek

• Feasibility assessment screening demonstrated <10% transfection of targeted lymphocytes or underamplification under CD3 / CD28 co-stimulation (<5-fold);

Egyéb

• Women who are pregnant or breastfeeding, or who have a pregnancy plan within six months;
• Abnormal vital signs, and unable to cooperate with the examination;
• The doctor believes there were other reasons for inclusion.

• The set subject inclusion criteria include multiple documents of multiple myeloma, no effective treatment options (e. g. autologous or allogeneic stem cell transplantation) and limited outcome (<2 years) with existing therapies, as follows:
• Age is 18~70 years old;
• Expected survival period of>12 weeks;
• Multiple myeloma was diagnosed by physical examination, pathological examination, laboratory examination and imaging;
• Patients with refractory multiple myeloma;
• Patients with multiple myeloma recurrence;
• ALT and AST <3 times normal; bilirubin <2.0mg / dl;
• Quality of survival score (KPS)> 50%;
• The patient has no serious heart, liver, kidney and other diseases;
• Recurrence or no disease remission after hematopoietic stem cell transplantation or cellular immunotherapy;
• Is not suitable for stem cell transplantation conditions or to abandon transplantation due to conditional restrictions;
• Blood can be obtained intravenously, without other contraindications to leukapheresis;
• Understand and voluntarily sign a written informed consent form.