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

NCT07309900 | Recruiting Phase 1

• 1 other identifier: IASO208CI001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed/Refractory B-cell Malignancies

Outcome Measures

Primary Outcomes (3)

• The incidence of dose-limiting toxicity (DLT);

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

  Up to 28 days from dosing

• 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.

  Up to 2 years from dosing

• 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.

  Up to 2 years from dosing

Secondary Outcomes (14)

• Objective response rate (ORR)

  Up to 2 years from dosing

• Objective response rate (ORR) at pre-specified timepoints

  Up to 2 years from dosing

• Complete response rate (CRR)

  Up to 2 years from dosing

• Duration of Response (DOR)

  Up to 2 years from dosing

• Time to Response (TTR)

  Up to 2 years from dosing

Other Outcomes (3)

• Percentage of participants with positive anti-drug antibodies (ADA)

  Up to 2 years from dosing

• Percentage of participants with Replication-Competent Lentivirus (RCL)

  Up to 15 years from dosing

• Percentage of participants with detectable viral particles in secretions following IASO208 administration.

  Up to 2 years from dosing

Study Arms (1)

IASO208 injection

EXPERIMENTAL

Genetic: IASO208 injection

Interventions

IASO208 injection GENETIC

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

IASO208 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• DLBCL transformed from indolent lymphoma (FL or MZL);
• Primary Mediastinal Large B-Cell Lymphoma (PMBCL).
• For B-cell lymphoma patients with relapsed/refractory diseases who have failed standard treatment (including relapse, non-remission, and progression), they must have received prior standard immunochemotherapy containing an anti-CD20 monoclonal antibody and an anthracycline-based regimen:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Nanjing IASO Biotechnology Co., Ltd.: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

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

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Heng Mei

CONTACT

+86 13886160811; mayheng@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 30, 2025
• Study Start: November 21, 2025
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): June 15, 2029
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)