JY232(JY232) Injection in Relapsed/Refractory Multiple Myeloma
ConditionMultiple Myeloma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenzhen Genocury Biotech Co., Ltd.
About this trial
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed/refractory multiple myeloma. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY232 injection in the treatment of relapsed/refractory multiple myeloma.
Eligibility criteria
Qualifiers
The subject voluntarily signs the informed consent form, is willing and able to comply with all study requirements.
Age 18-75 years, male or female.
Diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG).
Must have undergone stem cell transplantation (SCT) or be transplant-ineligible.
Disqualifiers
The subject's tumor sample (bone marrow) tests positive for B-Cell Maturation Antigen (BCMA) expression on the plasma cell membrane via immunohistochemistry (IHC) or flow cytometry.
Proportion of clonal plasma cells in bone marrow cytology, bone marrow biopsy histology, or flow cytometry ≥ 5%;
Serum monoclonal protein (M-protein) level: Immunoglobulin G (IgG) type M-protein ≥10 g/L; or Immunoglobulin A (IgA), Immunoglobulin D (IgD), Immunoglobulin E (IgE), Immunoglobulin M (IgM) type M-protein ≥5 g/L;
Urine M-protein level ≥200 mg/24 hours;
Trial design
Treatments tested in this trial
- JY232 Injection
Treatment groups
9 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov