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Relapsed/Refractory B-cell MalignanciesPhase 1NCT07309900

IASO208 Injection in the Treatment of Relapsed/Refractory B-cell Malignancies

A Phase 1 study testing IASO208 injection in people with Relapsed/Refractory B-cell Malignancies, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 is an investigator-initiated, single-arm, open-label clinical study. It employs a dose-escalation design to evaluate the safety, pharmacokinetics, and preliminary efficacy of IASO208 injection in relapsed/refractory B-cell malignancies. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Relapsed/Refractory B-cell Malignancies
What is being tested?
IASO208 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
21 Nov 2025to 15 Jun 2029
Phase
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

  • Subjects must meet all of the following criteria to be enrolled in this study:
  • Aged ≥18 years and ≤75 years.
  • Voluntary participation in this study and signing the informed consent form.
  • Prior histopathological biopsy confirming a diagnosis of one of the following pathological types:
  • Diffuse Large B-Cell Lymphoma (DLBCL), including High-Grade B-Cell Lymphoma (HGBL);
  • Grade 3b Follicular Lymphoma (FL3b);
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  • DLBCL transformed from indolent lymphoma (FL or MZL);
  • Primary Mediastinal Large B-Cell Lymphoma (PMBCL) and Mantle cell lymphoma.
  • For B-cell lymphoma patients with relapsed/refractory diseases who have failed standard treatment assessed by investigator (including relapse, non-remission, and progression);
  • Relapsed disease is defined as disease relapse or progression occurring ≥12 months after the end of prior therapy.
  • Refractory disease is defined as disease progression during treatment, best response of stable disease (SD), relapse within 12 months after autologous hematopoietic stem cell transplantation, or disease progression occurring within 12 months after the end of prior therapy.
  • CD20 positivity confirmed by detection on tumor biopsy specimens obtained after the last relapse or during the screening period.
  • Presence of at least one measurable lesion according to the Lugano 2014 criteria (nodal lesion with Long Axis Diameter [LDi] >1.5 cm, extranodal lesion with LDi >1.0 cm).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
  • Life expectancy ≥12 weeks.
  • Adequate organ function, as demonstrated by the following laboratory results
  • Hematology: Absolute Neutrophil Count (ANC) ≥1.0 × 10⁹/L; Absolute Lymphocyte Count (ALC) ≥0.3 × 10⁹/L; Platelet count (PLT) ≥50 × 10⁹/L; Hemoglobin (Hb) ≥70 g/L (must not have received any Granulocyte Colony-Stimulating Factor [G-CSF] or Granulocyte-Macrophage Colony-Stimulating Factor [GM-CSF] treatment, or transfusion of red blood cells or platelets within 7 days prior to the laboratory assessment).
  • Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × Upper Limit of Normal (ULN); Total Bilirubin ≤ 2 × ULN (for subjects with documented liver involvement by tumor: ALT/AST ≤5 × ULN; Total Bilirubin ≤3 × ULN).
  • Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥50%, as measured by echocardiography or Multigated Acquisition (MUGA) scan.
  • Oxygen saturation >92% (by pulse oximetry) at rest.
  • Renal function: Creatinine Clearance (CrCl) ≥40 mL/min, calculated using the Cockcroft-Gault formula.
  • Coagulation profile: Fibrinogen ≥1.0 g/L; Activated Partial Thromboplastin Time (aPTT) ≤1.5 × ULN; Prothrombin Time (PT) ≤1.5 × ULN.
  • Subjects of childbearing potential must agree to use highly effective contraceptive methods from the time of signing the informed consent form until at least 1 year after the last dose of IASO208 injection.

Who cannot join

  • Subjects who meet any of the following criteria will be excluded from this study:
  • Subjects with central nervous system involvement.
  • Subjects who have had other malignancies within 5 years prior to screening, except for appropriately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer, ductal carcinoma in situ of the breast, or papillary thyroid carcinoma.
  • Subjects who meet any of the following conditions in infectious disease screening:
  • Subjects positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with abnormal peripheral blood HBV DNA test (abnormal HBV DNA is defined as: quantitative detection higher than the lower limit of detection [LLD], above the normal range, or positive qualitative detection).
  • Subjects positive for hepatitis C virus (HCV) antibody with positive peripheral blood HCV RNA.
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  • Subjects positive for human immunodeficiency virus (HIV) antibody.
  • Subjects with syphilis.
  • Subjects with active cytomegalovirus (CMV) infection.
  • Uncontrolled active bacterial, fungal, or viral infection prior to enrollment, as evidenced by:
  • Persistent infection-related symptoms/signs requiring intravenous anti-infective therapy; or
  • No improvement in clinical symptoms or examinations after appropriate anti-infective therapy.
  • Severe cardiac diseases, including but not limited to: unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] Class ≥ III), or severe arrhythmia.
  • History of central nervous system diseases or disorders within 6 months prior to screening, such as epilepsy, paralysis, aphasia, cerebral infarction, cerebral hemorrhage, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome (e.g., cerebral aneurysm, epilepsy, stroke [except for lacunar infarction], dementia, psychosis), or subjects with impaired consciousness.
  • Previous solid organ transplantation.
  • Previous allogeneic hematopoietic stem cell transplantation (allo-HSCT), allogeneic CAR-T therapy, or other allogeneic donor adoptive cell therapies.
  • Subjects who do not meet the required washout periods for the following prior therapies/treatments before enrollment:
  • Cytotoxic chemotherapy, monoclonal antibodies, bispecific antibodies, or antibody-drug conjugates (ADCs) within 4 weeks prior to enrollment.
  • Ongoing requirement for systemic corticosteroids or other immunosuppressive therapy within 4 weeks prior to enrollment.
  • Radiotherapy or major surgery of Grade 4 severity within 4 weeks prior to enrollment; or planned general anesthesia surgery within 12 weeks after receiving the study treatment.
  • Vaccination or treatment with any investigational products within 4 weeks prior to enrollment.
  • Autologous hematopoietic stem cell transplantation or autologous CAR-T therapy within 12 weeks prior to enrollment.
  • Presence of other unstable systemic diseases, as determined by the investigator, including but not limited to severe hepatic, renal, or metabolic diseases requiring treatment.
  • Adverse events from previous anti-tumor therapies have not resolved to baseline or Grade ≤ 2 (excluding alopecia, fatigue, and peripheral neuropathy).
  • Known history of hypersensitivity to any excipient component of the IASO208 injection.
  • Pregnant or lactating women.
  • Any other condition deemed by the investigator as inappropriate for participation in the study.

Trial locations and contacts

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

Heng Mei contact

+86 13886160811

mayheng@126.com

China1 site, 1 recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Heng Mei, +8613886160811, mayheng@126.com

    Mei, mayheng@126.com

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Open-label Exploratory Clinical Study of IASO208 Injection in the Treatment of Relapsed/Refractory B-cell Malignancies

This is an investigator-initiated, single-arm, open-label clinical study. It employs a dose-escalation design to evaluate the safety, pharmacokinetics, and preliminary efficacy of IASO208 injection in relapsed/refractory B-cell malignancies.

Being tested
IASO208 injection
Keywords
in vivo CAR-T, CD20, IASO208, Relapsed/ Refractory B-cell malignancies
Medical subject headings
Recurrence

What participants receive

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

  • IASO208 injectionGenetic

    IASO208 injection is a third-generation, self-inactivated, replication-deficient Lentiviral Vector (LVV) gene therapy research drug.

Study groups in NCT07309900
Study groupRoleWhat they receive
IASO208 injectionExperimentalThere are 7 dose groups in the study, include 1E8 TU,3E8 TU,6E8 TU,9E8 TU,1.2E9 TU,1.5E9 TU,1.8E9 TU
Receives: Genetic: IASO208 injection

What is being measured

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

  1. The incidence of dose-limiting toxicity (DLT);

    Percentage of participants who experienced DLT within 28 days after IASO208 administration.

    Measured: Up to 28 days from dosing

  2. The incidence and severity of adverse events (AEs)

    Percentage of participants who experienced AEs after IASO208 administration and severity was graded according to the NCI-CTCAE version 5.0.

    Measured: Up to 2 years from dosing

  3. The types、incidence and severity of abnormal laboratory tests;

    The types、incidence and severity of abnormal laboratory results assessed by CTCAEV5.0 will be analyzed and reported.

    Measured: Up to 2 years from dosing

Secondary outcomes (14)

  1. Objective response rate (ORR)

    ORR was defined as the percentage of participants who achieved partial response (PR) or better as assessed by the investigator according to the Lugano 2014 Criteria.

    Measured: Up to 2 years from dosing

  2. Objective response rate (ORR) at pre-specified timepoints

    ORR at 3, 6, 12 months as assessed by the investigator according to the Lugano 2014 Criteria.

    Measured: Up to 2 years from dosing

  3. Complete response rate (CRR)

    CRR was defined as the percentage of participants who achieved complete response (CR) as assessed by the investigator according to the Lugano 2014 Criteria.

    Measured: Up to 2 years from dosing

  4. Duration of Response (DOR)

    DOR was defined as the time (in months) from the date of initial documented response (PR or better response) to the date of first documented evidence of progressive disease (PD) or death.

    Measured: Up to 2 years from dosing

  5. Time to Response (TTR)

    TTR was defined as the time between date of IASO208 administration and the first efficacy evaluation that the participant met all criteria for PR or better.

    Measured: Up to 2 years from dosing

  6. Progression-free Survival (PFS)

    PFS was defined as the time from the date of IASO208 administration to the date of first documented disease progression or death.

    Measured: Up to 2 years from dosing

  7. Overall Survival (OS)

    OS was defined as the time from the date of IASO208 administration to the date of the participant's death.

    Measured: Up to 2 years from dosing

  8. Maximum concentration (Cmax) of viral particle titer in peripheral blood following IASO208 administration

    Cmax of viral particle titer in peripheral blood will be observed and calculated.

    Measured: Up to 7 days from dosing

  9. Peak time (Tmax) of viral particle titer in peripheral blood following IASO208 administration

    Tmax of viral particle titer in peripheral blood will be observed and analyzed.

    Measured: Up to 7 days from dosing

  10. Area under the concentration-time curve from day 0 to day 7 (AUC0-7) of viral particle titer in peripheral blood following IASO208 administration

    AUC0-7d refers to the area under the concentration-time curve from day 0 (IASO208 dosing moment) to day 7 .

    Measured: Up to 7 days from dosing

  11. Concentration of vector copy numbers (VCN) in peripheral blood

    Concentration of VCN will be measured and reported following IASO208 administration.

    Measured: Up to 2 years from dosing

  12. CAR-T cell count in peripheral blood

    Concentration of CAR-T cell count will be observed and reported following IASO208 administration.

    Measured: Up to 2 years from dosing

  13. B lymphocytes in peripheral blood

    Concentration of B lymphocytes in peripheral blood will be observed following IASO208 administration.

    Measured: Up to 2 years from dosing

  14. Cytokines in peripheral blood

    Cytokines not limited to CRP、Ferritin 、、IL-6、IFN-γ、TNF-α in peripheral blood will be observed following IASO208 administration.

    Measured: Up to 2 years from dosing

Timeline

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

  1. First posted30 Dec 2025
  2. Study start21 Nov 2025
  3. Primary completion15 Dec 2028 (estimated)
  4. Study completion15 Jun 2029 (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
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
NCT07309900
Sponsor's protocol ID
IASO208CI001
Status last verified
May 2026
First submitted
26 Nov 2025
Last updated
1 Jun 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 Phase 1 study testing IASO208 injection in people with Relapsed/Refractory B-cell Malignancies, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 23 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 1 Jun 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Heng Mei (+86 13886160811, mayheng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of dose-limiting toxicity (DLT); (time frame: Up to 28 days from dosing). The study lists 3 primary outcomes in all. 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 NCT07309900.

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 1 Jun 2026.

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