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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Multiple Myeloma (MM)

Intervention / Treatment
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* Biological: OPC-415


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |