IASO104 for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
This study is a single-center, open-label, dose-exploration trial designed to evaluate the tolerability and safety of different doses of IASO104 in patients with relapsed/refractory plasma cell neoplasms, determine the recommended dose of IASO104, and assess its pharmacokinetic and pharmacodynamic characteristics. Additionally, the study will preliminarily observe the efficacy of the investigational drug in a small sample of subjects with relapsed/refractory multiple myeloma.
Eligibility criteria
Qualifiers
Age 18-75 years, any gender.
Diagnosis of multiple myeloma (MM) per International Myeloma Working Group (IMWG) diagnostic criteria.
1 proteasome inhibitor (PI)
1 immunomodulatory drug (IMiD)
Disqualifiers
Active graft-versus-host disease (GVHD) or requiring long-term immunosuppressive therapy.
Prior cell therapy targeting plasma cells within 3 months before apheresis, or detectable residual cellular therapy products in peripheral blood.
Chronic corticosteroid use (>20 mg/day prednisone or equivalent), except for physiologic replacement, topical, or inhaled use.
Uncontrolled hypertension despite medication.
Trial design
Treatments tested in this trial
- IASO104
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov