Relapsed/Refractory Multiple Myeloma (RRMM)Early Phase 1IASO104NCT07185490
IASO104 for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
A Early Phase 1 study testing IASO104 in people with Relapsed/Refractory Multiple Myeloma (RRMM) and Plasma Cell Leukemia (PCL), run by Institute of Hematology & Blood Diseases Hospital, China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma (RRMM), Plasma Cell Leukemia (PCL)
- What is being tested?
- IASO104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 15 Aug 2029
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 1 proteasome inhibitor (PI)
- 1 immunomodulatory drug (IMiD)
Show all 23Show fewer
- 1 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):
- Hematology:
- Absolute neutrophil count (ANC) ≥1×10⁹/L (allowed: growth factor support, but none within 7 days) Absolute lymphocyte count (ALC) ≥0.3×10⁹/L Platelets ≥50×10⁹/L (no transfusion within 7 days) Hemoglobin ≥60 g/L (no RBC transfusion within 7 days; erythropoietin allowed)
- Liver:
- ALT/AST ≤2.5×ULN Total bilirubin ≤1.5×ULN Renal: Calculated CrCl ≥40 mL/min (Cockcroft-Gault)
- Coagulation:
- Fibrinogen ≥1.0 g/L aPTT/PT ≤1.5×ULN Pulmonary: SpO₂ >91% (room air) Cardiac: LVEF ≥50% (echocardiography).
- Contraception: Subjects/partners must use effective contraception from consent through 1 year post CAR-T infusion (excluded: calendar method).
- Signed informed consent approved by the Ethics Committee prior to screening.
Who cannot join
- 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):
Show all 25Show fewer
- 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.
- Suspected or confirmed CNS involvement by plasma cell neoplasms.
- Major surgery within 2 weeks before apheresis or planned within 2 weeks post-treatment (allowed: minor procedures under local anesthesia).
- Investigational drugs within 1 month before apheresis.
- Uncontrolled active infections:
- Persistent symptoms despite appropriate therapy, Requiring IV antimicrobials at screening.
- Viral infections:
- HBV: HBsAg(+) or HBcAb(+) with detectable HBV DNA, HCV: HCV Ab(+) with detectable HCV RNA, HIV Ab(+), CMV DNA(+), Syphilis: TRUST(+) and TPPA(+).
- Pregnancy or lactation.
- Psychiatric disorders, cognitive impairment, or active CNS diseases.
- Other conditions deemed ineligible by the investigator.
About this study
Official title: Exploratory Clinical Study Protocol on the Safety and Efficacy of Fully Human BCMA-Targeted Chimeric Antigen Receptor Autologous T-Cell Injection (IASO104) for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
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.
Read the detailed description
This study adopts a "3+3" dose-escalation design, with three predefined dose levels: 0.5×10⁶ CAR-T cells/kg, 1.0×10⁶ CAR-T cells/kg, and 3.0×10⁶ CAR-T cells/kg, administered as a single infusion.For each dose group, the first subject must be observed for at least 2 weeks after infusion before subsequent subjects can be treated. If stable biological activity or clinical benefit is observed at a lower dose level, the study may proceed with 1-2 expanded dose groups at lower levels after discussion between the investigator and sponsor, without requiring MTD determination.During the dose-escalation phase, 2-3 subjects will be enrolled per dose level, with the total number of subjects depending on the escalation progression (estimated 4-6 subjects in this phase). Treatment in the next dose group may only begin after all subjects in the current group have completed DLT assessment post-infusion.
- Being tested
- IASO104
- Medical subject headings
- Multiple Myeloma, Leukemia, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IASO104Biological
IASO104 is a personalized, BCMA-targeted, genetically modified autologous T-cell immunotherapy product.
| Study group | Role | What they receive |
|---|---|---|
| IASO104 | Experimental | IASO104 will be administered in one infusion. Receives: Biological: IASO104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence and severity of adverse events (AEs)
Measured: Minimum 2 years after IASO104 infusion
Secondary outcomes (12)
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
Measured: Minimum 2 years after IASO104 infusion
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.
Measured: Minimum 2 years after IASO104 infusion
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.
Measured: Minimum 2 years after IASO104 infusion
Overall Survival (OS)
Overall survival (OS) was defined as the time from initiation of IASO104 injection treatment to death from any cause.
Measured: Minimum 2 years after IASO104 infusion
Time to Response (TTR)
Time to response (TTR) was defined as the interval from initiation of IASO104 injection treatment to first achievement of disease response (≥ partial response [PR]).
Measured: Minimum 2 years after IASO104 infusion
Time to Complete Response (TTCR)
Time to complete response (TTCR) was defined as the interval from initiation of IASO104 injection treatment to first achievement of complete response (CR) or better (including stringent complete response [sCR])
Measured: Minimum 2 years after IASO104 infusion
Minimal Residual Disease (MRD)-negative rate
Proportion of subjects achieving bone marrow minimal residual disease (MRD)-negativity by next-generation flow cytometry (NGF) following study treatment
Measured: Minimum 2 years after IASO104 infusion
Duration of MRD Negativity
Duration of MRD negativity was defined as the time from first achievement of MRD-negative status to first MRD recurrence (conversion to positive)
Measured: Minimum 2 years after IASO104 infusion
Pharmacokinetic (PK) Endpoints
Peak concentration (C<sub>max</sub>) of CAR-T cells
Area under the curve (AUC) over:
0-28 days post-infusion (AUC<sub>0-28d</sub>) 0-90 days post-infusion (AUC<sub>0-90d</sub>) 0-180 days post-infusion (AUC<sub>0-180d</sub>) Infusion to last measurable timepoint (AUC<sub>0-last</sub>)
Measured: Minimum 2 years after IASO104 infusion
Pharmacokinetic (PK) Endpoints
vector copy number (VCN) in peripheral blood Time to peak concentration (T<sub>max</sub>)
Area under the curve (AUC) over:
0-28 days post-infusion (AUC<sub>0-28d</sub>) 0-90 days post-infusion (AUC<sub>0-90d</sub>) 0-180 days post-infusion (AUC<sub>0-180d</sub>) Infusion to last measurable timepoint (AUC<sub>0-last</sub>)
Measured: Minimum 2 years after IASO104 infusion
Pharmacodynamic (PD) Endpoints
Levels of soluble BCMA (sBCMA) in peripheral blood at each timepoint
Measured: Minimum 2 years after IASO104 infusion
Pharmacodynamic (PD) Endpoints
concentrations of CAR-T-related inflammatory biomarkers (including CRP, IL-6, and ferritin)
Measured: Minimum 2 years after IASO104 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start15 Feb 2026 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple Myeloma (RRMM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185490
- Sponsor's protocol ID
- IIT2025081
- Other IDs
- Nanjing Reindeer Biotechnology
- Acronym
- IASO104
- Status last verified
- Nov 2025
- First submitted
- 5 Sep 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No