Clinical trial · Interventional
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
NCT07248163CI-TRIAL-00097927recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-center, single-arm, open-label clinical study, and the sample size is set to 3-6 subjects.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-hodgkin Lymphoma,B Cell | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BRL-301 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- 5×10\^6/kgBW
- interventionNames
- Drug: BRL-301
Primary outcomes (1)
- measure
- DLT
- timeFrame
- Within 28 Days After BRL-301 Infusion
- description
- The number and severity of dose-limiting toxicity (DLT) events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.