IASO206 in Patients With Relapsed/Refractory Multiple Myeloma
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
This study is an open-label, single-arm early exploratory clinical study, aiming to evaluate the safety, tolerability and preliminary efficacy of IASO206 Injection(In Vivo CAR-T) in Patients with Relapsed/Refractory Multiple Myeloma
Eligibility criteria
Qualifiers
18 to 75 years old, male or female;
Diagnosed with relapsed/refractory multiple myeloma (RRMM) according to IMWG criteria, and have received at least 2 lines of treatment including one proteasome inhibitor and one immunomodulator; with documented disease progression (based on examination data) during or within 12 months after the latest anti-myeloma treatment (subjects whose last-line treatment was CAR-T therapy are not required to have progression within 12 months);
Serum monoclonal protein (M-protein) level: ≥5 g/L f；
Urine M protein level ≥200 mg/24 hours;
Disqualifiers
Patients with suspected or confirmed central nervous system involvement by plasma cell neoplasms;
Multiple myeloma patients with plasma cell leukemia;
Patients with amyloidosis;
Patients who have received autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks before enrollment, or have a history of allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
Trial design
Treatments tested in this trial
- IASO206 injection
Treatment groups
12 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov