BCMA/CD3 BiTE for RRAL or NDAL Amyloidosis With Insufficient Depth of Hematologic Response After Induction Therapy

Inclusion Criteria

• •Male or female patients aged 18 years or older
• •Biopsy-proven diagnosis of AL amyloidosis, according to the following standard criteria:
• •Histochemical diagnosis of amyloidosis, as based on tissue specimens with Congo red staining with exhibition of an apple-green birefringence
• •If clinical and laboratory parameters are insufficient to establish AL amyloidosis, or in cases of doubt, amyloid typing may be necessary
• •Provide informed consent form
• •Measurable disease, as defined by serum differential free light-chain concentration (dFLC; defined as the difference between amyloid forming \[involved\] and nonamyloid forming \[uninvolved\] free light-chain \[FLC\]) ≥50 mg/L)
• •Received at least one prior line of therapy
• •Must have been exposed to CD38 mAb
• •Relapsed/refractory AL amyloidosis or newly diagnosed AL amyloidosis with insufficient depth of hematologic response after induction therapy
• •Relapsed is defined as documented progressive disease \>60 days after the last dose of prior therapy
• •Refractory is defined as the documented absence of a hematologic response or hematologic progression on or within 60 days after the last dose of prior therapy
• •Insufficient depth of hematologic response is defined as less than hematological PR by 2 cycles or less than hematologic VGPR by 4 cycles
• •Eastern Cooperative Oncology Group performance status ≤3
• •Clinical laboratory values:
• •Absolute neutrophil count ≥1000/µL
• •Platelet count ≥75,000/µL
• •Hemoglobin ≥75g/L
• •Total bilirubin ≤1.5× the upper limit of normal (ULN), except for patients with Gilbert's syndrome (as defined by \>80% unconjugated bilirubin and total bilirubin ≤6 mg/dL)
• •Alkaline phosphatase ≤5× ULN
• •Alanine aminotransferase or aspartate aminotransferase ≤3× ULN
• •Calculated creatinine clearance ≥30 mL/min
• •The woman is not breastfeeding, is not pregnant, and agrees not to be pregnant during the study period and for the following 12 months.
• •Male patients agreed that their spouse would not become pregnant during the study period and for 12 months thereafter.