Clinical trial · Interventional
Safety and Efficacy Study of OPC-415 in Patients With Relapsed and/or Refractory Multiple Myeloma
A Multicenter, Uncontrolled, Nonrandomized, Open-Label, Phase 1/2 Trial Investigating the Safety and Efficacy of OPC 415 in MMG49 Antigen-Positive Patients With Relapsed and/or Refractory Multiple Myeloma
NCT04649073CI-TRIAL-00090152terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Why stopped (as posted): This is because the decision was made to conclude the trial at Phase I and not proceed to Phase II.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OPC-415 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OPC-415 (up to 1×10^7cells/kg)
- interventionNames
- Biological: OPC-415
Primary outcomes (2)
- measure
- Phase1: Dose Limiting Toxicity
- timeFrame
- Day1~Day28
- measure
- Phase2: Response rate
- timeFrame
- Day1~Day366
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.