Universal CAR-T therapy for CD19-positive B‑cell non-Hodgkin lymphoma

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

This study will try an off‑the‑shelf CAR‑T product called BRL‑301 in adults with CD19‑positive B‑cell non‑Hodgkin lymphoma to see if a single 5×10^6/kg dose is safe and shows anti‑tumor activity.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bioray Laboratories (Industry-sponsored)
• Drugs / interventions: CAR-T, immunotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT07248163 on ClinicalTrials.gov

What this trial studies

This is a single‑center, single‑arm, open‑label study enrolling 3–6 adult subjects with measurable CD19‑positive B‑cell non‑Hodgkin lymphoma. Participants receive a fixed dose of BRL‑301 (5×10^6 cells/kg) and are followed for safety, tolerability, and signs of clinical response. Key eligibility includes ECOG 0–1, adequate organ function, LVEF ≥55%, and no prior anti‑CD19 or CAR‑T therapies. The study aims primarily to characterize early safety and any preliminary efficacy signals of this universal CAR‑T approach.

Who should consider this trial

Good fit: Adults (≥18) with measurable, CD19‑positive B‑cell non‑Hodgkin lymphoma, ECOG 0–1, adequate blood, coagulation and biochemistry values, LVEF ≥55%, estimated survival ≥3 months, and who have not received prior CAR‑T, allogeneic cell therapy, or anti‑CD19 targeted therapy.

Not a fit: Patients who are pregnant or lactating, have had prior CAR‑T or allogeneic cell therapy, prior anti‑CD19 targeted therapy, uncontrolled infections, positive hepatitis B markers, severe pulmonary disorders, or poor organ function are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, BRL‑301 could offer an off‑the‑shelf CAR‑T option that produces anti‑lymphoma responses without the wait and complexity of patient‑derived manufacturing.

How similar studies have performed: Autologous CD19 CAR‑T therapies have produced strong responses in B‑cell NHL, but off‑the‑shelf (universal) CAR‑T approaches are newer and have produced promising but still early and mixed results.

Eligibility criteria

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.

Where this trial is running

Shanghai

• Shanghi Tongji Hospital (Tongji Hospital of Tongji University) — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Ping Li, phD

Conditions Non-hodgkin Lymphoma,B Cell