A Study of GC012F (AZD0120), a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma

Inclusion Criteria:

• Males and females ≥18 years of age at the time of consent

• Written informed consent in accordance with federal, local, and institutional guidelines

• Have an ECOG performance status of 0 or 1

• Documented diagnosis of MM per IMWG diagnostic criteria

• Received at least three prior MM treatment lines of therapy

• Have received as part of their previous therapy a PI and IMiD and an antiCD38 antibody.

• Have documented evidence of progressive disease by the IMWG criteria.

• Subjects must have measurable disease at screening, as defined by any of the following: serum monoclonal paraprotein (M-protein) ≥1.0g/dL (10 g/L); urine M-protein ≥200 mg/24 h; serum FLC assay: involved FLC level is ≥10 mg/dL (100 mg/L) and serum kappa lambda FLC ratio is abnormal.

• Adequate bone marrow and organ function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP

Exclusion Criteria :

• Diagnosed or treated for invasive malignancy other than multiple myeloma, except: Malignancy treated with curative intent and with no known active disease present for ≥2 years before enrollment; or

• Adequately treated non-melanoma skin cancer without evidence of disease.

• The following cardiac conditions:

• New York Heart Association (NYHA) stage III or IV congestive heart failure

• Myocardial infarction or coronary artery bypass graft (CABG) ≤6 months prior to enrollment

• History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration

• History of severe non-ischemic cardiomyopathy

• Received either of the following:

• An allogenic stem cell transplant within 6 months before apheresis. Subjects who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD).

• An autologous stem cell transplant ≤12 weeks before apheresis

• Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.

• Plasma cell leukemia at the time of screening (>2.0×109 /L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL amyloidosis.