Safety and Efficacy Study of OPC-415 in Patients With Relapsed and/or Refractory Multiple Myeloma
Safety and Efficacy Study of OPC-415 in Patients With Relapsed and/or Refractory Multiple Myeloma
The purpose of this study is to evaluate the tolerability,safety and efficacy of OPC-415 in
 patients with relapsed and/or refractory Multiple Myeloma (MM).
Inclusion Criteria:

 -  Patients aged between 20 and 80 (75 for the phase 1 part) years, both inclusive, at
 the time of consent

 -  Patients with a definitive diagnosis of active multiple myeloma

 -  Patients who have had 2 or more prior regimens (including all proteasome inhibitors,
 immunomodulators, and anti-CD38 antibody)

 -  Patients with relapsed and/or refractory Multiple Myeloma

 -  Patients who are positive for MMG49 antigen

 -  Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS)
 score of 0 or 1. Those with an ECOG-PS score of 2 due solely to MM bone lesions can be
 enrolled

 -  Patients who are expected to survive for at least 3 months

 Exclusion Criteria:

 -  Patients who are scheduled to receive high-dose chemotherapy in combination with
 autologous stem cell transplantation as the next treatment.

 -  Patients who have other active double/multiple cancers

 -  Patients on continuous and systemic (oral or intravenous) medication with
 corticosteroids or other immunosuppressive agents

 -  Patients with graft-versus-host disease that requires treatment.

 -  Patients who underwent a highly invasive and extensive surgical procedure within 2
 weeks.

 -  Patients who previously underwent allogeneic stem cell transplantation or organ
 transplantation.

 -  Patients who underwent autologous stem cell transplantation within 90 days.

 -  Patients with systemic amyloidosis (except localized amyloidosis without organ
 derangement) or plasma cell leukemia.

 -  Patients with prior or current central nerve involvement in MM.

 -  Patients whose best ever response to MM treatment is PD.

 -  Patients who previously received gene therapy or cell therapy (except hematopoietic
 stem cell transplantation).

 -  Pregnant women, nursing mothers, or women with a positive pregnancy test.