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Relapsed/Refractory Multiple Myeloma (RRMM)Early Phase 1NCT07322159

IASO206 in Patients With Relapsed/Refractory Multiple Myeloma

A Early Phase 1 study testing IASO206 injection in people with Relapsed/Refractory Multiple Myeloma (RRMM), run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
IASO206 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
8 Jan 2026to 15 Oct 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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%;
  • Left ventricular ejection fraction (LVEF) ≥50%;
  • Subjects and their spouses agree to use effective contraceptive methods with tools or drugs from the time the subject signs the informed consent form until one year after administration;
  • Subjects must sign a written informed consent form approved by the ethics committee before initiating the screening process.

Who cannot join

  • 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;
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  • 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；
  • Patient who needs chronic use of immunosuppressive agents;
  • Patients with malignant tumors other than multiple myeloma within 5 years before screening, excluding fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and those after radical resection Ductal carcinoma in situ of breast and papillary thyroid carcinoma;
  • Patients with a history of solid organ transplantation;
  • Major surgery history within 2 weeks before entering the study, or scheduled surgery during the study period or within 2 weeks after the study treatment；
  • Serious uncontrolled infections during screening: Bacterial, viral, fungal, etc. infections;
  • Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and detectable hepatitis B virus (HBV) DNA in peripheral blood; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus ( HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA test positive; syphilis test positive;
  • Patients who have received inactivated vaccines within 4 weeks before enrollment;
  • Women who are pregnant or breastfeeding;
  • Patients with mental illness, consciousness disorder, or central nervous system diseases, including but not limited to epilepsy or a history of Parkinson's disease;
  • Known severe allergic reaction to IASO206 or its formulation components (such as tocilizumab);
  • Patients with unresolved non-hematological toxic reactions from previous treatments, which have not returned to baseline or ≤Grade 1 (except for alopecia and Grade 2 peripheral neuropathy);
  • Other situations considered unsuitable by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjin

    pu chang Cao, +86 13584069411, changpu.cao@iasobio.com

    gang An

    Recruiting

Other trials in China

About this study

Official title: An Exploratory Study of Safety and Efficacy of IASO206 in Patients With Relapsed/Refractory Multiple Myeloma

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

Being tested
IASO206 injection
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IASO206 injectionDrug

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

Study groups in NCT07322159
Study groupRoleWhat they receive
IASO206Active comparatorIASO206 will be administered in one infusion.
Receives: Drug: IASO206 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: up to 2 years after IASO206 infusion

Secondary outcomes (10)

  1. Overall response rate (ORR)

    The proportions of subjects achieving stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), and Partial Response (PR) after IASO206 infusion.

    Measured: up to 2 years after IASO206 infusion

  2. Time to response (TTR)

    The time from the start of the drug infusion in subjects to the first occurrence of sCR, CR, VGPR, or PR.

    Measured: up to 2 years after IASO206 infusion

  3. MRD negativity rate

    The proportion of subjects who achieve MRD-negativity after IASO206 infusion.

    Measured: up to 2 years after IASO206 infusion

  4. Duration of response (DOR)

    The time from the first assessment of sCR or CR or VGPR or PR to the first assessment of disease progression or death from any cause.

    Measured: up to 2 years after IASO206 infusion

  5. Progression-free survival (PFS)

    The time from the date IASO206 infusion to the date of first disease progression or death from any cause (whichever occurs first)

    Measured: up to 2 years after IASO206 infusion

  6. Overall survival (OS)

    The time from the date of IASO206 infusion to the date of death from any reason.

    Measured: up to 2 years after IASO206 infusion

  7. Pharmacodynamics（PD）

    The levels of cytokines (IL-6, serum ferritin, CRP) in peripheral blood at each time point，and lymphocyte subsets after IASO206 infusion.

    Measured: up to 2 years after IASO206 infusion

  8. Pharmacokinetic Analysis（PK）

    Maximum concentration (Cmax) of IASO206 particle and CAR-T cells.

    Measured: up to 24 month after IASO206 infusion

  9. Pharmacokinetic Analysis（PK）

    Time of maximum concentration (Tmax) of IASO206 particle and CAR-T cells.

    Measured: up to 24 month after IASO206 infusion

  10. Pharmacokinetic Analysis（PK）

    Area under the concentration versus time curve: IASO206 particle AUC0-12d; CAR-T cell AUC0-28d,AUC0-90d,AUC0-180d,AUC0-last

    Measured: up to 24 month after IASO206 infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2026
  2. Study start8 Jan 2026
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion15 Oct 2028 (estimated)

Resources

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
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07322159
Sponsor's protocol ID
IIT2025097
Status last verified
Oct 2026
First submitted
9 Dec 2025
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing IASO206 injection in people with Relapsed/Refractory Multiple Myeloma (RRMM), run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence and severity of adverse events（AEs） (time frame: up to 2 years after IASO206 infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07322159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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