A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis

Key Inclusion Criteria:

Each patient must meet the following criteria to be enrolled in this study.

   1. AL amyloidosis Mayo stage I, II or IIIa

   2. For Part A only, measurable hematologic disease defined by at least one of the
   following:

      1. involved/uninvolved free light chain difference (dFLC) > 5mg/dL or

      2. free light chain (FLC) > 5mg/dL with abnormal Kappa/Lambda ratio or

      3. serum protein electrophoresis (SPEP) m- spike > 0.5 g/dL Patients with confirmed
      AL amyloid diagnosis without measurable disease may be enrolled with consultation
      and approval by the Sponsor Medical Monitor or their designee.

   3. a. For Part A, currently on and continuing OR planned to start concurrent chemotherapy
   with CyBorD administered weekly as SoC. b. For Part B, currently on and continuing OR
   planned to start concurrent chemotherapy with CyBorD and daratumumab administered as
   SoC.

Key Exclusion Criteria:

Patients who meet any of the following criteria will not be permitted entry to the study.

   1. Any form of secondary, hereditary, senile, localized, dialysis-related or leukocyte
   chemotactic factor 2-related (ALECT2) amyloidosis

   2. Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma.
   Patients with signs and/or symptoms attributable ONLY to amyloidosis and who do NOT
   meet IMWG definition of smoldering myeloma may be enrolled upon approval of the
   medical monitor.

   3. Supine systolic blood pressure < 90 mmHg or symptomatic orthostatic hypotension,
   defined as a decrease in systolic blood pressure upon standing of > 20 mmHg despite
   medical management (e.g., midodrine, fludrocortisones) in the absence of volume
   depletion

   4. Receiving dialysis

   5. Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular
   arrhythmias, or percutaneous cardiac intervention with recent stent, coronary artery
   bypass grafting or major cerebrovascular accident within 6 months prior to screening

   6. Left ventricular ejection fraction (LVEF) < 45 percent by echocardiogram or multigated
   acquisition scan (MUGA)