RecruitingNot ApplicableNCT07248163

Universal CAR-T Cell Therapy for NHL

A Clinical Study of the Safety and Efficacy of Universal CAR-T Cells Targeting CD19 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma

Sponsor

Bioray Laboratories

Enrollment

6 participants

Start Date

Mar 11, 2025

Study Type

INTERVENTIONAL

Conditions

Non-hodgkin Lymphoma,B Cell

Summary

This is a single-center, single-arm, open-label clinical study, and the sample size is set to 3-6 subjects.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

Willing to participate in this clinical study and sign an informed consent form;
Age ≥ 18 years old;
Estimated survival time ≥ 3 months;
At least one measurable lesion;
CD19 positively expressed;
ECOG score 0-1；
Hematology, coagulation and biochemistry parameters meeting the requirements;
LVEF ≥ 55%;
No severe pulmonary disorders;

Exclusion Criteria13

Pregnant or lactating women;
Subjects who previously received allogeneic cell therapies, including allogeneic stem cell transplant;
Subjects who previously received anti-CD19 targeted therapy;
Prior treatment with any CAR-T cell product or other genetically modified T cell therapies;
History of Richter's transformation of chronic lymphocytic leukemia (CLL);
Presence of uncontrollable fungal, bacterial, viral, or other infections requiring systemic therapy;
Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer higher than the upper limit of detection; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;
Severe mental disorders; history of CNS disorders (e.g., epileptic seizure, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any CNS-involved autoimmune disorders);
Active autoimmune disorders requiring immunotherapy, including but not limited to end organ damages caused by autoimmune disorders (e.g., Crohn's disease, rheumatoid arthritis, and systemic lupus erythematosus) in the past 2 years, or requiring systemic application of immunosuppressive drugs or other drugs for systemic control of diseases;
Primary immunodeficiency;
History of other malignancies;
Patients with severe cardiovascular disorders;
Any circumstances that possibly increase the risk of subjects or interfere with the study results as judged by the investigator.