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Clinical Trials in China / NCT07248163
Recruiting Not applicable

Universal CAR-T Cell Therapy for NHL

NCT07248163 · tracked via the Priya Life Science China tracker
Sponsor
Bioray Laboratories
Phase
Not applicable
Started
2025-03-11
Last updated
2025-11-25

Condition(s) studied

Non-hodgkin Lymphoma,B Cell

Investigational drug(s) / intervention(s)

BRL-301

BRL-301: The administered dose is 5×10\^6/kg

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Willing to participate in this clinical study and sign an informed consent form; 2. Age ≥ 18 years old; 3. Estimated survival time ≥ 3 months; 4. At least one measurable lesion; 5. CD19 positively expressed; 6. ECOG score 0-1; 7. Hematology, coagulation and biochemistry parameters meeting the requirements; 8. LVEF ≥ 55%; 9. No severe pulmonary disorders; Exclusion Criteria: 1. Pregnant or lactating women; 2. Subjects who previously received allogeneic cell therapies, including allogeneic stem cell transplant; 3. Subjects who previously received anti-CD19 targeted therapy; 4. Prior treatment with any CAR-T cell product or other genetically modified T cell therapies; 5. History of Richter's transformation of chronic lymphocytic leukemia (CLL); 6. Presence of uncontrollable fungal, bacterial, viral, or other infections requiring systemic therapy; 7. 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; 8. Severe mental disorders; history of CNS disorders (e.g., epileptic seizure, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any CNS-involved autoimmune disorders); 9. 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; 10. Primary immunodeficiency; 11. History of other malignancies; 12. Patients with severe cardiovascular disorders; 13. Any circumstances that possibly increase the risk of subjects or interfere with the study results as judged by the investigator.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghi Tongji Hospital (Tongji Hospital of Tongji University) Shanghai China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07248163 on ClinicalTrials.gov ↗ ← All trials in China