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