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

A Multicenter, Uncontrolled, Nonrandomized, Open-Label, Phase 1/2 Trial Investigating the Safety and Efficacy of OPC 415 in MMG49 Antigen-Positive 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).

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma (MM)
• Intervention / Treatment: Biological: OPC-415

• Study Type: Interventional
• Enrollment (Estimated): 49
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Drug Information Center; Phone Number: +81-3-6361-7314

Study Locations

• Japan
  • Isehara-shi, Japan
    • Recruiting
    • Tokai University Hospital
  • Okayama-shi, Japan
    • Not yet recruiting
    • National Hospital Organization Okayama Medical Center
  • Sendai-shi, Japan
    • Recruiting
    • Tohoku University Hospital
  • Shibuya-ku, Japan
    • Recruiting
    • Japanese Red Cross Medical Center
  • Suita-shi, Japan
    • Recruiting
    • Osaka University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OPC-415 (up to 1×10^7cells/kg)	Biological: OPC-415; OPC-415 (up to 1×10^7cells/kg) On 2 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Investigators: Study Director: Nobuhito Sanada, Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2041

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: 415-102-00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: :The focus of this study is a rare disease.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No