This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability, preliminary efficacy and immunogenicity of OriV508 injection for patients with relapsed/refractory hematological malignancies.
Aged 18 - 75 years.
ECOG scores 0-1.
Expected survival time ≥ 12 weeks.
Have a record of confirmed multiple myeloma (MM) according to IMWG criteria, or a record of histologically confirmed aggressive B-cell non-Hodgkin lymphoma (B-NHL). According to the definition of the 2022 World Health Organization (WHO) classification, the pathological types of aggressive B-NHL include: diffuse large B-cell lymphoma, not otherwise specified; diffuse large B-cell lymphoma/high-grade B-cell lymphoma with MYC and BCL2 rearrangements; high-grade B-cell lymphoma, not otherwise specified; primary mediastinal B-cell lymphoma; mantle cell lymphoma; grade 3b follicular lymphoma; large B-cell lymphoma transformed from indolent B-NHL.
Small molecule targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is longer;
Immunosuppressive agent therapy (such as tacrolimus, mycophenolate mofetil, etc.) within 28 days;
Monoclonal antibody treatment within 21 days;
Cytotoxic therapy within 14 days;
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Huazhong University of Science and Technology
Sponsor institution
OriCell Therapeutics Co., Ltd.
Collaborator