NCT07322159
Not yet recruiting
Early Phase 1
An Exploratory Study of Safety and Efficacy of IASO206 in Patients With Relapsed/Refractory Multiple Myeloma
Institute of Hematology & Blood Diseases Hospital, China0 sites12 target enrollmentStarted: January 15, 2026Last updated:
InterventionsIASO206 injection
Overview
- Phase
- Early Phase 1
- Status
- Not yet recruiting
- Enrollment
- 12
- Primary Endpoint
- The incidence and severity of adverse events（AEs）
Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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);
- •Presence of measurable lesions during screening according to any of the following criteria:
- •Serum monoclonal protein (M-protein) level: ≥5 g/L f；
- •Urine M protein level ≥200 mg/24 hours;
- •Light chain multiple myeloma without measurable lesions in serum or urine: the affected serum free light chain ≥100 mg/L with abnormal serum κ/λ free light chain ratio;
- •BCMA expression on MM cells determined by flow cytometry or pathology immunohistochemistry;
- •ECOG score ≤ 2;
- •Expected survival time ≥12 weeks;
- •Subjects must have adequate organ function:
Exclusion Criteria
- •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);
- •Patients who have received previous BCMA-targeted therapy;
- •Patients who have received plasma cell-targeted cellular therapy within 3 months before the screening period, or in whom received cellular therapy products can still be detected in peripheral blood;
- •Patients who have received other anti-tumor treatments requires an appropriate washout period：
- •Received Bendamustine, fludalabine or high-dose cyclophosphoyl within 9 months before enrollment，or；
- •Received Monoclonal antibody treatment for multiple myeloma within 21 days before enrollment, or;
- •Received cytotoxic chemotherapy or proteasome inhibitor treatment within 14 days before enrollment, or；
Arms & Interventions
IASO206
Active Comparator
IASO206 will be administered in one infusion.
Intervention: IASO206 injection (Drug)
Outcomes
Primary Outcomes
The incidence and severity of adverse events（AEs）
Time Frame: up to 2 years after IASO206 infusion
Cytokine release syndrome (CRS) and ICANS would be graded according to the ASTCT consensus. All other AEs would be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Secondary Outcomes
- Overall response rate (ORR)(up to 2 years after IASO206 infusion)
- Time to response (TTR)(up to 2 years after IASO206 infusion)
- MRD negativity rate(up to 2 years after IASO206 infusion)
- Duration of response (DOR)(up to 2 years after IASO206 infusion)
- Progression-free survival (PFS)(up to 2 years after IASO206 infusion)
- Overall survival (OS)(up to 2 years after IASO206 infusion)
- Pharmacodynamics（PD）(up to 2 years after IASO206 infusion)
- Pharmacokinetic Analysis（PK）(up to 24 month after IASO206 infusion)
Investigators
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