Safety and Efficacy Study of OPC-415 in Patients With Relapsed and/or Refractory Multiple Myeloma

Multiple Myeloma (MM) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04649073
• Other study ID #: 415-102-00001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 18, 2021
• Est. completion date: January 2041

Study information

• Verified date: June 2023
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: Drug Information Center
• Phone: +81-3-6361-7314
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 49
• Est. completion date: January 2041
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma (MM)
• Neoplasms, Plasma Cell

Intervention

Biological:
• OPC-415
OPC-415 (up to 1×10^7cells/kg) On 2 days

Locations

Country	Name	City	State
Japan	Tokai University Hospital	Isehara-shi
Japan	National Hospital Organization Okayama Medical Center	Okayama-shi
Japan	Tohoku University Hospital	Sendai-shi
Japan	Japanese Red Cross Medical Center	Shibuya-ku
Japan	Osaka University Hospital	Suita-shi

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase1: Dose Limiting Toxicity		Day1~Day28
Primary	Phase2: Response rate	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.	Day1~Day366