Trials Sponsors Conditions Drugs Pricing

Conditions

Relapsed/Refractory B-cell Malignancies

Keywords

in vivo CAR-TCD20IASO208Relapsed/ 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
+9 more secondary outcomes

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

There 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

Genetic: IASO208 injection

Interventions

IASO208 injectionGenetic

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

IASO208 injection

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Shanghai IASO Biotechnology Co., Ltd
Industrycollaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Otherlead

Study Sites (1)

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

Wuhan, Hubei, 430022, China

RECRUITING

Heng MeiCONTACT+8613886160811 mayheng@126.com

MeiCONTACTmayheng@126.com

Heng MEI, PhDPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological 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

Actual (reported)

Primary Completion

December 15, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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.
+12 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (14)

Other Outcomes (3)

Study Arms (1)

IASO208 injection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (14)

Other Outcomes (3)

Study Arms (1)

IASO208 injection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations