A single-arm, open-label, multicenter, dose-escalation clinical trial to evaluate the safety, tolerability, and preliminary efficacy of KIV-318 Injection in patients with relapsed/refractory multiple myeloma.
Age between 18 and 70 years (inclusive), regardless of gender;
Diagnosis of multiple myeloma (MM) confirmed per the IMWG diagnostic criteria. and presenting with relapsed/refractory (r/r) MM following at least ≥3 prior lines of therapy. Prior therapies must have included proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and/or CD38 monoclonal antibodies. While prior exposure to all three therapeutic classes is preferred, subjects must have received at least two of these treatment categories (PIs, IMiDs, and/or anti-CD38) during their prior therapy;
Subjects with r/r MM at screening, with documented disease progression, or who are considered refractory, either during or within 12 months after the most recent anti-myeloma treatment.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 , and an estimated life expectancy of ≥3 months.
Receipt of any type of T-cell engager (TCE) therapy within 8 weeks or 5 half-lives (whichever is shorter) prior to the first dose of the investigational drug.
Receipt of proteasome inhibitors, immunomodulatory agents, radiotherapy, or traditional Chinese medicine preparations approved for anti-tumor indications within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of the investigational drug.
Presence of meningeal, brainstem, or spinal cord metastasis and/or compression, or active central nervous system (CNS) metastasis.
Receipt of allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 6 months prior to infusion, or autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months prior to infusion.
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Shenzhen Pregene Biopharma Co., Ltd.
Collaborator