Multiple Myeloma (MM)
Conditions
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).
Interventions
BIOLOGICALOPC-415
OPC-415 (up to 1×10\^7cells/kg) On 2 days
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Contacts
STUDY_DIRECTORNobuhito Sanada
Otsuka Pharmaceutical Co., Ltd.
Outcome results
None listed