Safety and Efficacy Study of OPC-415 in Patients With Relapsed and/or Refractory Multiple Myeloma
- Registration Number
- NCT04649073
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 11
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description OPC-415 (up to 1×10^7cells/kg) OPC-415 -
- Primary Outcome Measures
Name Time Method Phase1: Dose Limiting Toxicity Day1~Day28 Phase2: Response rate Day1~Day366 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Nagoya City University Hospital
🇯🇵Nagoya-shi, Japan
Sapporo Medical University Hospital
🇯🇵Sapporo-shi, Japan
Yamagata University Hospital
🇯🇵Yamagata-shi, Japan
Tokai University Hospital
🇯🇵Isehara-shi, Japan
National Hospital Organization Okayama Medical Center
🇯🇵Okayama-shi, Japan
Tohoku University Hospital
🇯🇵Sendai-shi, Japan
Japanese Red Cross Medical Center
🇯🇵Shibuya-ku, Japan
Osaka University Hospital
🇯🇵Suita-shi, Japan