IASO104 for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

NCT07185490 | Not Yet Recruiting Early Phase 1

• 2 other identifiers: IIT2025081Nanjing Reindeer Biotechnology
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Relapsed/Refractory Multiple Myeloma (RRMM); Plasma Cell Leukemia (PCL)

Outcome Measures

Primary Outcomes (1)

• incidence and severity of adverse events (AEs)

  Minimum 2 years after IASO104 infusion

Secondary Outcomes (12)

• Overall Response Rate (ORR)

  Minimum 2 years after IASO104 infusion

• Duration of Response (DOR)

  Minimum 2 years after IASO104 infusion

• Progression-Free Survival (PFS)

  Minimum 2 years after IASO104 infusion

• Overall Survival (OS)

  Minimum 2 years after IASO104 infusion

• Time to Response (TTR)

  Minimum 2 years after IASO104 infusion

Study Arms (1)

IASO104

EXPERIMENTAL

IASO104 will be administered in one infusion.

Biological: IASO104

Interventions

IASO104 BIOLOGICAL

IASO104 is a personalized, BCMA-targeted, genetically modified autologous T-cell immunotherapy product.

IASO104

Eligibility Criteria

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

You may qualify if:

• Age 18-75 years, any gender.
• Diagnosis of multiple myeloma (MM) per International Myeloma Working Group (IMWG) diagnostic criteria.
• Prior therapy requirements:
• MM patients: ≥3 prior lines of therapy, including:
• proteasome inhibitor (PI)
• immunomodulatory drug (IMiD)
• anti-CD38 monoclonal antibody Exception: No minimum line requirement for subjects refractory to PIs, IMiDs, and anti-CD38 therapy.
• Primary plasma cell leukemia (pPCL): ≥1 prior line including ≥1 PI and ≥1 IMiD.
• Documented disease progression during/within 12 months after last anti-myeloma therapy (exemption: No 12-month requirement if last line was CAR-T).
• Measurable disease at screening (≥1 of the following):
• Serum M-protein:
• IgG ≥10 g/L IgA/IgD/IgE/IgM ≥5 g/L Urine M-protein ≥200 mg/24h Serum free light chains (FLC): Involved FLC ≥100 mg/L with abnormal κ/λ ratio Bone marrow plasma cells ≥30% (if no measurable M-protein/FLC).
• ECOG performance status 0-1.
• Life expectancy ≥12 weeks.
• Adequate organ function (all lab values within 7 days prior to enrollment):

You may not qualify if:

• Active graft-versus-host disease (GVHD) or requiring long-term immunosuppressive therapy.
• Prior hematopoietic stem cell transplantation (HSCT):
• Autologous HSCT (Auto-HSCT) within 12 weeks before apheresis,
• ≥2 prior Auto-HSCTs, Any prior allogeneic HSCT (Allo-HSCT).
• Prior cell therapy targeting plasma cells within 3 months before apheresis, or detectable residual cellular therapy products in peripheral blood.
• Recent anti-myeloma therapies (relative to apheresis):
• Monoclonal antibody treatment within 21 days, Cytotoxic chemotherapy or proteasome inhibitors within 14 days, Immunomodulatory drugs within 7 days, Other anti-tumor therapies within 14 days or 5 half-lives (whichever is shorter).
• Chronic corticosteroid use (\>20 mg/day prednisone or equivalent), except for physiologic replacement, topical, or inhaled use.
• Uncontrolled hypertension despite medication.
• Severe cardiac disease, including:
• Unstable angina, Myocardial infarction (within 6 months before screening), Congestive heart failure (NYHA Class ≥III), Severe arrhythmias.
• Unstable systemic illnesses per investigator's judgment (e.g., severe hepatic, renal, or metabolic disorders requiring medication).
• Other malignancies within 5 years, excluding:
• Carcinoma in situ of the cervix, Basal/squamous cell skin cancer, Localized prostate cancer post-radical resection, Ductal breast carcinoma in situ post-resection.
• History of solid organ transplantation.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Multiple Myeloma; Leukemia, Plasma Cell

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; Leukemia

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: September 5, 2025
• First Posted: September 22, 2025
• Study Start: February 15, 2026
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 15, 2029
• Last Updated: January 20, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share