A Study of AC676 for the Treatment of Relapsed/Refractory B-Cell Malignancies

Prior treatment

• Treatment with any of the following:
  • Small molecule anti-cancer drugs within 5 half-lives or 2 days (whichever is longer, not to exceed 14 days).
  • Systemic chemotherapy within 14 days.
  • Radiation therapy within 14 days
  • Biologics (Antibodies) treatment within 28 days,
  • Radioimmunoconjugates or toxin conjugates within 12 weeks.
  • Prior Chimeric antigen receptor (CAR) T cell therapy (and prior use of immunoglobulin replacement therapy to treat associated adverse events) within 3 months. For patients with DLBCL, no prior CAR- T therapy is allowed.
  • Autologous or allogenic stem cell transplant within 100 days and must not have ongoing graft-versus-host disease (GVHD) and no ongoing therapy to treat GVHD.
• Medical history of active bleeding within 2 months prior to study entry, or susceptible to bleeding by the judgement of investigator.

Other illness

• History of central nervous system lymphoma/leukemia in remission for less than 2 years.

Other

• Patients who meet any of the following criteria will be excluded from study entry:

• Adult male and female patients, at least 18 years-of-age at the time of signature of the informed consent form (ICF).
• Patients with histologically confirmed relapsed/refractory Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL), non-GCB Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL), or Waldenström Macroglobulinemia (WM).
• Must have received at least 2 prior systemic therapies or have no other therapies to provide significant clinical benefit in the opinion of the Investigator or who are not amenable (intolerability, patient choice) to standard therapies.