Clinical Trial 23586

• Overview

  Study Title:

  A Phase 1b/2 Study of AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against CD19 and B-cell Maturation Antigen (BCMA) in Participants with Relapsed/Refractory Multiple Myeloma

  Objective:

  Primary Objectives: Phase 1b: - To evaluate the safety and tolerability of GC012F in subjects with relapsed/refractory MM - To determine the recommended Phase 2 dose (RP2D) of GC012F Phase 2: - To evaluate the efficacy of GC012F in subjects with relapsed/refractory MM Secondary Objectives: Phase 1b: - To characterize the PK of GC012F Phase 2: - To further characterize the safety of GC012F Phase 1b and 2: - To further characterize the efficacy of GC012F - To assess the pharmacodynamics of GC012F - To assess the immunogenicity of GC012F - To assess changes from baseline for subject-reported health-related quality of life, overall health status Exploratory: - To explore whether the infused CAR+ T-cell subsets impact PD, safety, and clinical activity of GC012F - To determine whether replication competent lentivirus is present in subjects that receive GC012F - To explore whether there are predictive biomarkers of response or resistance to GC012F - To determine if MRD negative rate predicts DOR, PFS, OS

• Treatments

  Therapies:

  Cell Therapy; Chemotherapy (NOS)

  Medications:

  AZD0120 (); GC012F (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

• Inclusion Criteria

  Key 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.
  • Additional criteria may apply.

• Exclusion Criteria

  Key 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.
  • 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.
  • Additional criteria may apply.

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