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

NCT04649073 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: 415-102-00001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 8

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)

Outcome Measures

Primary Outcomes (2)

• Phase1: Dose Limiting Toxicity

  Day1~Day28

• Phase2: Response rate

  The proportion of subjects who achieved partial response or better outcomes by central assessment based on IMWG Uniform Response Criteria for Multiple Myeloma will be calculated.

  Day1~Day366

Study Arms (1)

OPC-415 (up to 1×10^7cells/kg)

EXPERIMENTAL

Biological: OPC-415

Interventions

OPC-415 BIOLOGICAL

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

OPC-415 (up to 1×10^7cells/kg)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (8)

Tokai University Hospital

Isehara-shi, Japan

Location

Nagoya City University Hospital

Nagoya, Japan

Location

National Hospital Organization Okayama Medical Center

Okayama, Japan

Location

Sapporo Medical University Hospital

Sapporo, Japan

Location

Tohoku University Hospital

Sendai, Japan

Location

Japanese Red Cross Medical Center

Shibuya-ku, Japan

Location

Osaka University Hospital

Suita-shi, Japan

Location

Yamagata University Hospital

Yamagata, Japan

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Nobuhito Sanada

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: February 18, 2021
• Primary Completion: April 9, 2025
• Study Completion (Estimated): January 1, 2041
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (8)