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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
IASO104
Biological/VaccineIASO104 is a personalized, BCMA-targeted, genetically modified autologous T-cell immunotherapy product.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: IASO104Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
incidence and severity of adverse events (AEs)
Time frame
Minimum 2 years after IASO104 infusionSecondary outcomes
1
Overall Response Rate (ORR)
The proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) after treatment with IASO104 injection
Time frame
Minimum 2 years after IASO104 infusion2
Duration of Response (DOR)
Duration of response (DOR) was defined as the time from the first documented achievement of response (≥ partial response \[PR\]) to disease progression or death from any cause (whichever occurred first) in subjects treated with IASO104 injection.
Time frame
Minimum 2 years after IASO104 infusion3
Progression-Free Survival (PFS)
Progression-free survival (PFS) was defined as the time from initiation of IASO104 injection treatment to disease progression or death from any cause, whichever occurred first.
Time frame
Minimum 2 years after IASO104 infusion4
Overall Survival (OS)
Overall survival (OS) was defined as the time from initiation of IASO104 injection treatment to death from any cause.
Time frame
Minimum 2 years after IASO104 infusionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: