APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma

Korábbi kezelés

• 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;

Más betegség

• 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;

Laborértékek

• 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;

Egyéb

• 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 BCMA/TACI+ multiple myeloma (MM)：
  • Patients with MM relapsed after BCMA CAR-T therapy; Or MM with positive BCMA/TACI expression;
  • 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.
• Male or female aged 18-75 years;
• Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
• Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
• No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
• Estimated survival time ≥ 3 months;
• ECOG performance status 0 to 2;
• Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.