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

NCT ID: NCT04649073

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-18
• Study Completion Date: 2041-01-31

Brief Summary

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).

Conditions

Multiple Myeloma (MM)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OPC-415 (up to 1×10^7cells/kg)

Group Type: EXPERIMENTAL

OPC-415

Intervention Type: BIOLOGICAL

OPC-415 (up to 1×10\^7cells/kg) On 2 days

Interventions

OPC-415

OPC-415 (up to 1×10\^7cells/kg) On 2 days

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nobuhito Sanada

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

Tokai University Hospital

Isehara-shi, , Japan

Nagoya City University Hospital

Nagoya, , Japan

National Hospital Organization Okayama Medical Center

Okayama, , Japan

Sapporo Medical University Hospital

Sapporo, , Japan

Tohoku University Hospital

Sendai, , Japan

Japanese Red Cross Medical Center

Shibuya-ku, , Japan

Osaka University Hospital

Suita-shi, , Japan

Yamagata University Hospital

Yamagata, , Japan

Countries

Japan

Other Identifiers

415-102-00001

Identifier Type: -

Identifier Source: org_study_id