About this trial
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。
Eligibility criteria
Qualifiers
1. Age ≥ 18 years old and ≤ 75 years old.
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- IASO207 Injection