Description:
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).
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).
Recruiting
Phase 1/Phase 2
Drug | Synonyms | Arms |
---|---|---|
OPC-415 | OPC-415 (up to 1×10^7cells/kg) |
Name | Type | Description | Interventions |
---|---|---|---|
OPC-415 (up to 1×10^7cells/kg) | Experimental |
|
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.
Maximum Eligible Age: | 80 Years |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Phase1: Dose Limiting Toxicity |
Time Frame: | Day1~Day28 |
Safety Issue: | |
Description: | 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. |
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Otsuka Pharmaceutical Co., Ltd. |
March 3, 2021