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MalignanciesEarly Phase 1NCT07574346

IASO207 Injection in the Treatment of Relapsed/Refractory B-cell Malignancies

A Early Phase 1 study testing IASO207 Injection in people with Malignancies, run by Peking University People's Hospital 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
Search all trials

Trial summary

This is a single-center, open-label, exploratory clinical study to evaluate the efficacy and safety of IASO207 Injection in patients with Relapsed/Refractory B-cell Malignancies。 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignancies
What is being tested?
IASO207 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
29 May 2026to 30 Apr 2042
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

  • 1. Age ≥ 18 years old and ≤ 75 years old.
  • 2. Previously diagnosed by histopathological biopsy as one of the following pathological types:
  • Diffuse large B-cell lymphoma, not otherwise specified (DLBCL NOS); high-grade B-cell lymphoma (HGBL);
  • DLBCL transformed from indolent lymphoma, including transformation from follicular lymphoma (FL) or marginal zone lymphoma (MZL), and DLBCL transformed from CLL/SLL (Richter transformation);
  • Grade 3B follicular lymphoma (FL3B); primary mediastinal large B-cell lymphoma (PMBCL).
  • 3. Recurrent/refractory B-cell lymphoma patients who have failed standard treatment (including recurrence, non-response, progression) must have received a standard immunotherapy regimen containing CD20 monoclonal antibody and anthracycline drugs:
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  • Recurrent disease refers to the occurrence of disease recurrence or progression ≥ 12 months after treatment;
  • Refractory disease refers to disease progression during treatment or best response of disease stability (SD), or recurrence within 12 months after autologous hematopoietic stem cell transplantation, or disease progression within 12 months after treatment.
  • 4. Before enrollment, it is confirmed that CD19 target expression is positive:
  • Previous pathological results indicate positive CD19 expression, and/or;
  • Can provide archived or fresh puncture specimens to the central laboratory for detection to confirm positive CD19 expression.
  • 5. According to the Lugano 2014 standard, there is at least one measurable lesion (lymph node lesion LDi > 1.5 cm, extranodal lesion LDi > 1.0 cm);( LDi is longest diameter)
  • 6. ECOG score 0-2;
  • 7. Expected survival period ≥ 12 weeks;
  • 8. Screening period examination confirms appropriate organ function: i. Blood routine: absolute neutrophil count (ANC) ≥ 1×109/L; platelets (PLT) ≥ 50×109/L; hemoglobin (Hb) ≥ 70g/L (must not have received any G-CSF/GM-CSF treatment or red blood cell and platelet transfusion within 7 days before laboratory examination); ii. Peripheral blood T lymphocyte absolute count ≥ 300 cells/μL; iii. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× upper limit of normal (ULN); serum total bilirubin ≤ 1.5× ULN (for patients with tumor liver metastasis: ALT/AST ≤ 5× ULN; TBil ≤ 3× ULN); iv. Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%; v. Pulmonary function: oxygen saturation at rest ≥ 91%; vi. Renal function: calculated creatinine clearance rate (CrCl) ≥ 40 ml/min according to Cockcroft-Gault formula; vii. Coagulation function: fibrinogen ≥ 1.0g/L; activated partial thromboplastin time (aPTT) ≤ 1.5× ULN, prothrombin time (PT) ≤ 1.5× ULN;
  • 9. Pregnant participants should agree to take effective contraceptive measures or drugs from the date of signing the informed consent form until at least 1 year after the last administration of IASO207 injection.

Who cannot join

  • 1. There is invasion of central nervous system tumors; and/or primary central nervous system DLBCL, primary testicular LBCL.
  • 2. The tumor involves the small intestine, colon, and/or imaging examination indicates that the tumor involves the sub-mucosal layer of the gastrointestinal tract, and the patient has been evaluated to have a risk of organ perforation.
  • 3. Within the past 5 years before screening, the subject has had other malignant tumors except for the disease under study, excluding cervical carcinoma in situ after radical treatment, basal cell or squamous cell skin cancer after radical treatment, local prostate cancer, breast duct carcinoma in situ or thyroid papillary carcinoma.
  • 4. Infectious disease screening meets one of the following conditions: i. The subject has positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and abnormal peripheral blood HBV DNA test (abnormal HBV DNA test is defined as: HBV DNA quantitative test higher than the detection center's lower limit or higher than the normal reference range of the detection center or HBV DNA qualitative test positive); ii. The subject has positive hepatitis C virus (HCV) antibody and positive peripheral blood HCV RNA; iii. The subject has positive human immunodeficiency virus (HIV) antibody; iv. The subject has syphilis; v. The subject is an active CMV infection patient.
  • 5. Before enrollment, there is uncontrollable active bacterial, fungal or viral infection: i. There are persistent symptoms/signs related to infection that require intravenous anti-infection drug treatment; ii. After appropriate anti-infection treatment, the clinical symptoms and examinations do not indicate improvement.
  • 6. Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA functional classification standard ≥ III), severe arrhythmia.
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  • 7. Within the past 6 months before screening, the subject has had central nervous system diseases or histories, such as epilepsy, paralysis, aphasia, cerebral infarction, cerebral hemorrhage, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome (such as cerebral aneurysm, epilepsy, stroke [except lacunar infarction], senile dementia, psychosis, etc.) or patients with consciousness disorders.
  • 8. The subject has received any CD19-targeted treatment before.
  • 9. The subject has received any allogeneic hematopoietic stem cell transplantation (Allo-HSCT), autologous CAR-T and other allogeneic donor cell adoptive therapy.
  • 10. The subject with a large mass (diameter of the lesion > 7.5 cm) is not included in this study; patients whose disease progresses too rapidly and is expected not to benefit from the treatment of this study will not be included in this study.
  • 11. Before enrollment, the subject does not meet the drug/treatment washout period: i. The subject needs or is continuously using systemic corticosteroids or other immunosuppressants within 4 weeks before enrollment; ii. The subject has received bispecific antibody, autologous hematopoietic stem cell transplantation, autologous CAR-T treatment within 12 weeks before enrollment; iii. The subject has received radiotherapy or grade 4 major surgery within 4 weeks before enrollment; or plans to undergo general anesthesia surgery within 12 weeks after receiving the study treatment.
  • Using monoclonal antibodies, cytotoxic chemotherapy, or ADC drugs within 4 weeks prior to enrollment; v. Having received vaccination or any off-label clinical study drug treatment within 4 weeks prior to enrollment.
  • 12. Judged by the investigator, there are other unstable systemic diseases: including but not limited to severe liver, kidney or metabolic diseases that require treatment.
  • 13. The adverse reactions caused by previous anti-tumor treatment have not been alleviated to ≤ grade 2 (NCI-CTCAE v5.0 version).
  • 14. Those with a history of allergic reactions to the excipient components of IASO207 injection.
  • 15. Those who have received solid organ transplantation in the past.
  • 16. Pregnant or lactating women.
  • 17. Other situations deemed by the investigator as not suitable for enrollment.

Trial locations and contacts

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

Jin Lu, PhD contact

+86 13311491805

jin1lu@sina.com

Xuelin Dou，PhD contact

+86 18514559556

dxldw@163.com

China1 site, 1 recruiting

  • Peking University People's Hospital

    Beijing, 100044

    Jin Lu, PhD, +86 13311491805, jin1lu@sina.com

    Xuelin Dou，PhD, +86 18514559556, dxldw@163.com

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Dose-escalation Clinical Study Evaluating the Safety, Pharmacokinetics and Preliminary Efficacy of IASO207 Injection in Subjects With Relapsed/Refractory B-cell Malignancies

This is a single-center, open-label, exploratory clinical study to evaluate the efficacy and safety of IASO207 Injection in patients with Relapsed/Refractory B-cell Malignancies。

Read the detailed description

This study is a single-arm, single-center, open-label First-in-Human clinical trial (FIH), aiming to preliminarily evaluate the safety and efficacy of IASO207 injection in patients with Relapsed/Refractory B-cell Malignancies,and to determine the recommended dose for subsequent clinical trials. The "3+3" dose-escalation design was adopted in the dose-escalation stage, and three dose-escalation dose groups of 5.0×10^8 TU, 1.0×10^9 TU and 2.0×10^9 TU were preset. Each dose group level included 3-6 subjects with a single dose. The objective is to preliminarily observe the safety and tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of IASO207 injection at different doses in patients with Relapsed/Refractory B-cell Malignancies and provide evidence for subsequent clinical trials.

Conditions
Malignancies
Being tested
IASO207 Injection
Keywords
Relapsed, Refractory, B-cell malignancies, IASO207
Medical subject headings
Neoplasms, Recurrence

What participants receive

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

  • IASO207 InjectionDrug

    IASO207 is a third-generation replication-deficient self-inactivating lentiviral vector that carries the gene encoding a second-generation anti-human CD19 chimeric antigen receptor (CD19 CAR) containing the 4-1BB co-stimulatory factor. IASO207 has been engineered through surface modification of the lentiviral envelope to enable it to selectively bind and transduce T cells within the body, thereby directly generating CD19 CAR-T cells in vivo.

Study groups in NCT07574346
Study groupRoleWhat they receive
IASO207 InjectionExperimentalIASO207 Injection will be infused at 5.0×10^8 TU or 1.0×10^9 TU or 2.0×10^9 TU after enrollment.
Receives: Drug: IASO207 Injection

What is being measured

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

  1. Safety endpoint - Adverse Events (AEs)

    Incidence and severity of adverse events as assessed by NCI-CTCAE v5.0 (except CRS and ICANS per 2019 ASTCT criteria).

    Measured: up to 2 years from IASO207 Injection infusion

  2. Safety endpoint - The incidence of dose-limiting toxicity (DLT)

    Percentage of participants who experienced DLT within 28 days after IASO207 administration.

    Measured: up to 28 days from IASO207 Injection infusion

  3. Safety endpoint - 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 IASO207 Injection infusion

Secondary outcomes (21)

  1. Efficacy endpoint - 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 IASO207 Injection infusion

  2. Efficacy endpoint - 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 IASO207 Injection infusion

  3. Efficacy endpoint - 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 IASO207 Injection infusion

  4. Efficacy endpoint - 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 IASO207 Injection infusion

  5. Efficacy endpoint - Time to Response (TTR)

    TTR was defined as the time between date of IASO207 administration and the first efficacy evaluation that the participant met all criteria for PR or better.

    Measured: up to 2 years from IASO207 Injection infusion

  6. Efficacy endpoint - Time to complete Response (TTCR)

    Time from IASO207 Injection infusion to first documentation of complete response.

    Measured: up to 2 years from IASO207 Injection infusion

  7. Efficacy endpoint - Progression-free Survival (PFS)

    PFS was defined as the time from the date of IASO207 administration to the date of first documented disease progression or death.

    Measured: up to 2 years from IASO207 Injection infusion

  8. Efficacy endpoint - Overall Survival (OS)

    OS was defined as the time from the date of IASO207 administration to the date of the participant's death.

    Measured: up to 2 years from IASO207 Injection infusion

  9. Pharmacokinetic Endpoint - Cmax (viral particle)

    Maximum concentration (Cmax) of viral particle titer in peripheral blood will be observed and calculated.

    Measured: Up to 7 days from IASO207 Injection infusion

  10. Pharmacokinetic Endpoint - Tmax (viral particle)

    Peak time (Tmax) of viral particle titer in peripheral blood will be observed and analyzed.

    Measured: Up to 7 days from IASO207 Injection infusion

  11. Pharmacokinetic Endpoint - AUC0-7 (viral particle)

    AUC0-7d refers to the area under the concentration-time curve from day 0 to day 7.

    Measured: Up to 7 days from IASO207 Injection infusion

  12. Pharmacokinetic Endpoint - Cmax (CAR-T cells)

    The maximum concentration (Cmax) of CAR-T cells in peripheral blood after infusion.

    Measured: up to 60 days from IASO207 Injection infusion

  13. Pharmacokinetic Endpoint - Tmax (CAR-T cells)

    The time for CAR-T cells to reach the maximum concentration (Tmax) after infusion.

    Measured: up to 60 days from IASO207 Injection infusion

  14. Pharmacokinetic Endpoint - AUC (CAR-T cells)

    Area under the curve of 28 days and the last time point of PK measurement (AUC0-28d, AUC0-last) for CAR-T cells.

    Measured: up to 60 days from IASO207 Injection infusion

  15. Pharmacokinetic Endpoint - Cmax (VCN)

    The maximum concentration (Cmax) of lentiviral vector copy number (VCN) in peripheral blood after infusion.

    Measured: up to 2 years from IASO207 Injection infusion

  16. Pharmacokinetic Endpoint - Tmax (VCN)

    The time for VCN to reach the maximum concentration (Tmax) after infusion.

    Measured: up to 2 years from IASO207 Injection infusion

  17. Pharmacokinetic Endpoint - AUC (VCN)

    Area under the curve of 28 days, 90 days, 180 days, and the last time point (AUC0-28d, AUC0-90d, AUC0-180d, AUC0-last) for VCN.

    Measured: up to 2 years from IASO207 Injection infusion

  18. Pharmacodynamic Endpoint - Changes in absolute count and percentage of B cells subsets in peripheral blood

    To evaluate changes in the absolute count (cells/μL) and percentage of B cells in peripheral blood, measured by flow cytometry.

    Measured: up to 2 years from IASO207 Injection infusion

  19. Pharmacodynamic Endpoint - CRP

    Changes in the levels of CRP.

    Measured: up to 2 years from IASO207 Injection infusion

  20. Pharmacodynamic Endpoint - Ferritin

    Changes in the levels of Ferritin.

    Measured: up to 2 years from IASO207 Injection infusion

  21. Pharmacodynamic Endpoint - IL-6

    Changes in the levels of IL-6.

    Measured: up to 2 years from IASO207 Injection 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 May 2026
  2. Study start29 May 2026
  3. Primary completion30 Apr 2029 (estimated)
  4. Study completion30 Apr 2042 (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
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07574346
Sponsor's protocol ID
IASO207CI001
Status last verified
Jun 2026
First submitted
18 Apr 2026
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing IASO207 Injection in people with Malignancies, run by Peking University People's Hospital 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 16 inclusion and 18 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 18 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?

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?

Contact Jin Lu, PhD (+86 13311491805, jin1lu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety endpoint - Adverse Events (AEs) (time frame: up to 2 years from IASO207 Injection infusion). 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 NCT07574346.

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 18 Jun 2026.

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