IASO206 in Patients With Relapsed/Refractory Multiple Myeloma

NCT07322159 | Not Yet Recruiting Early Phase 1

• 1 other identifier: IIT2025097
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Conditions

Relapsed/Refractory Multiple Myeloma (RRMM)

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of adverse events（AEs）

  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).

  up to 2 years after IASO206 infusion

Secondary Outcomes (10)

• 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

Study Arms (1)

IASO206

ACTIVE COMPARATOR

IASO206 will be administered in one infusion.

Drug: IASO206 injection

Interventions

IASO206 injection DRUG

The third-generation self-inactivating lentiviral vector that carries a BCMA-targeted CAR.

IASO206

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Hematology: Absolute neutrophil count (ANC) ≥ 1×10\^9/L (supportive treatment within 7 days before laboratory test is not allowed); Absolute lymphocyte count (ALC) )≥0.3×10\^9/L; platelets≥50×10\^9/L (blood transfusion support within 7 days before laboratory test is not allowed); hemoglobin ≥60 g/L (without red blood cell \[RBC\] transfusion within 7 days before laboratory test);
• Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤1.5×upper limit of normal (ULN); serum total bilirubin≤1.5×ULN;
• Renal function: creatinine clearance calculated according to Cockcroft-Gault formula≥ 40 ml/min.
• Coagulation function: fibrinogen ≥1.0 g/L; activated partial thromboplastin time≤1.5×ULN, prothrombin time (PT)≤1.5×ULN;
• Blood oxygen saturation\>91%;

You may not qualify if:

• 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；
• Received immunomodulatory treatment within 7 days before enrollment, or;
• Received other anti-tumor treatments (including but not limited to experimental drugs) listed above within 14 days before enrollment or at least 5 half-lives (whichever is longer);
• Patients requiring long-term use of therapeutic doses of corticosteroids during the study period (defined as prednisone or equivalent \>20 mg/day), except for physiological replacement, topical, and inhaled use;
• Severe heart diseases：including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association \[NYHA\] classification ≥ grade III), severe arrhythmia，hypertension that cannot be controlled by medication;
• Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases；

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 7, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2028
• Last Updated: January 7, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share