Safety and Efficacy Study of OPC-415 in Patients With Relapsed and/or Refractory Multiple Myeloma

Otsuka

Status and phase

Active, not recruiting

Phase 2

Phase 1

Conditions

Multiple Myeloma (MM)

Treatments

Biological: OPC-415

Study type

Interventional

Funder types

Industry

Identifiers

NCT04649073

415-102-00001

Details and patient eligibility

About

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).

Enrollment

11 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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.