Study of NXC-201 CAR-T in Patients With Light Chain (AL) Amyloidosis (NEXICART-2)

Inclusion Criteria: ≥18 years of age Voluntarily signed informed consent form (ICF) Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 Histologically-proven systemic AL confirmed by positive Congo red staining with green birefringence on polarized light microscopy in an organ outside the bone marrow and evidence of a measurable clonal disease that requires active treatment. Relapsed disease or need for additional therapy after 1 or more prior lines of therapy as determined by the treating physician meeting one of the following criteria: Intolerant of initial therapy and has not achieved a hematologic Very good partial response (VGPR). Loss of hematologic response as defined has an increase the difference between involved and uninvolved free light chains >40 mg/DL (4 mg/L) Inadequate response to initial therapy defined as achieving at least a hematologic VGPR after at least 4 cycles of initial therapy. Relapsed AL amyloidosis post allogenic stem cell transplantation without evidence of graft versus host disease after cessation of any immunosuppressive therapy (IST) for at least one month before recruitment to the study. Subjects must have measurable disease at screening, including at least one of the criteria below: Serum M-protein greater or equal to 0.5 g/dL Serum free light chain (FLC) assay (both must be present): involved FLC level greater or equal to 50 mg/L (5 mg/dL) serum FLC ratio is abnormal Concurrent multiple myeloma is NOT excluded as long as end organ involvement with AL amyloidosis is demonstrated. Women of child-bearing potential (WCBP), must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study Recovery to ≤Grade 2 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 3 neuropathy Ability and willingness to adhere to the study visit schedule and all protocol requirements Exclusion Criteria: Any prior systemic therapy for AL amyloidosis within 14 days prior to leukapheresis Long-acting growth factors or drugs used for cell mobilization within 14 days prior to leukapheresis Short-acting growth factors or drugs used for cell mobilization within 5 days prior to leukapheresis Therapeutic doses of steroids within 3 days prior to leukapheresis Palliative radiation, if urgently needed, is allowed between screening and lymphodepletion Any prior systemic therapy for AL amyloidosis within 14 days prior to the start of lymphodepletion. Central nervous system (CNS) directed radiation within 8 weeks prior to lymphodepletion Long-acting growth factors or drugs used for cell mobilization within 14 days prior to lymphodepletion Short-acting growth factors or drugs used for cell mobilization within 3 days prior to lymphodepletion Investigational cellular therapies within 8 weeks prior to lymphodepletion Subjects with known bulky central nervous system disease Inadequate hepatic function: Alanine aminotransferase (ALT) >3 normal value Inadequate renal function: creatinine clearance (CRCL) < 20. International ratio (INR) or partial thromboplastin time (PTT) > 1.5 x ULN (Upper limit of normal), unless on a stable dose of anticoagulant for a thromboembolic event that does NOT meet exclusion criteria Inadequate bone marrow function defined by absolute neutrophil count (ANC) < 1000 cells/mm^3, platelet count < 30,000 mm^3, or hemoglobin < 8 g/dL (blood transfusions are allowed), absolute lymphocyte count < 300 cells/mm^3. Ongoing treatment with chronic immunosuppressants Presence of active infection within 72 hours prior to lymphodepletion Significant co-morbid condition or disease which in the judgment of the Investigator would place the subject at undue risk or interfere with the study Known human immunodeficiency virus (HIV) positive status subjects who have not achieved undetectable viral load on Highly active antiretroviral therapy / combination antiretroviral therapy (HAART/CAART) within 6 months of lymphodepletion Active Hepatitis B or Hepatitis C infection Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within 3 months. Left ventricular ejection fraction < 40% Heart failure which is, in the opinion of the investigator, related to ischemic heart disease Subjects with second malignancies in addition to myeloma, if the second malignancy has required therapy in the last 2 years or is not in complete remission; exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy or any other malignancy in remission with the written permission from treating oncologist. Subjects who have had a venous thromboembolic event requiring anticoagulation and who meet any of the following criteria: Have been on a stable dose of anticoagulation for < 1 month (except for acute line insertion induced thrombosis) Have had a Grade 2, 3, or 4 hemorrhage in the last 30 days Are experiencing continued symptoms from their venous thromboembolic event (e.g., continued dyspnea or oxygen requirement) Pregnant or lactating women