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

NCT07574346 | Not Yet Recruiting Early Phase 1

• 1 other identifier: IASO207CI001
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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。

Conditions

Malignancies

Keywords

Relapsed; Refractory; B-cell malignancies; IASO207

Outcome Measures

Primary Outcomes (3)

• 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).

  up to 2 years from IASO207 Injection infusion

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

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

  up to 28 days from IASO207 Injection infusion

• 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.

  up to 2 years from IASO207 Injection infusion

Secondary Outcomes (21)

• Efficacy endpoint - Objective response rate (ORR)

  up to 2 years from IASO207 Injection infusion

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

  up to 2 years from IASO207 Injection infusion

• Efficacy endpoint - Complete response rate (CRR)

  up to 2 years from IASO207 Injection infusion

• Efficacy endpoint - Duration of Response (DOR)

  up to 2 years from IASO207 Injection infusion

• Efficacy endpoint - Time to Response (TTR)

  up to 2 years from IASO207 Injection infusion

Other Outcomes (6)

• Immunogenicity

  up to 2 years from IASO207 Injection infusion

• Replication competent lentivirus (RCL)

  up to 2 years from IASO207 Injection infusion

• Virus shedding

  Up to 7 days from IASO207 Injection infusion

Study Arms (1)

IASO207 Injection

EXPERIMENTAL

IASO207 Injection will be infused at 5.0×10\^8 TU or 1.0×10\^9 TU or 2.0×10\^9 TU after enrollment.

Drug: IASO207 Injection

Interventions

IASO207 Injection DRUG

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.

IASO207 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:

• \. Age ≥ 18 years old and ≤ 75 years old.
• \. 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).
• \. 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:
• 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.
• \. 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.
• \. 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)
• \. ECOG score 0-2;
• \. Expected survival period ≥ 12 weeks;
• \. 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;

You may not qualify if:

• \. There is invasion of central nervous system tumors; and/or primary central nervous system DLBCL, primary testicular LBCL.
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. The subject has received any CD19-targeted treatment before.
• \. The subject has received any allogeneic hematopoietic stem cell transplantation (Allo-HSCT), autologous CAR-T and other allogeneic donor cell adoptive therapy.
• \. 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.
• \. 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.
• iv. 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.
• \. Judged by the investigator, there are other unstable systemic diseases: including but not limited to severe liver, kidney or metabolic diseases that require treatment.
• \. The adverse reactions caused by previous anti-tumor treatment have not been alleviated to ≤ grade 2 (NCI-CTCAE v5.0 version).
• \. Those with a history of allergic reactions to the excipient components of IASO207 injection.

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor, Chief Physician of Hematology Department

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: May 7, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2042
• Last Updated: May 7, 2026

Record last verified: 2026-05