Phase 1/2 trial to evaluate the safety and efficacy of OPC-415
- Conditions
- Multiple myeloma (MM)
- Registration Number
- JPRN-jRCT2033200278
- Lead Sponsor
- Sanada Nobuhito
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 49
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.
-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 D63(except appropriately treated basal cell carcinoma/skin squamous cell carcinoma/intraepithelial carcinoma of the uterine, prostate/breast cancer stabilized by endocrine therapies, and malignancies that have not relapsed for at least 1 year since the last successful treatment).
-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
- Not specified
- Primary Outcome Measures
Name Time Method Phase1: Dose Limiting Toxicity<br>Phase2: Response rate
- Secondary Outcome Measures
Name Time Method