Relma-cel Followed by Tislelizumab for the Treatment of Relapsed/Refractory CNS Large B-Cell Lymphoma

Launched by RUIJIN HOSPITAL · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment approach for patients with relapsed or refractory central nervous system (CNS) large B-cell lymphoma, which is a type of cancer affecting the brain and spinal cord. The study will involve giving participants an infusion of a treatment called Relma-cel, followed by another medication called Tislelizumab after 35 days. Participants will receive Tislelizumab every four weeks for a year. The trial is looking to see how well this combination works, how safe it is, and how the drugs behave in the body over time.

To be eligible for this trial, participants must be at least 18 years old and have previously been treated for their lymphoma but still have the disease. They should have a good performance status, meaning they can carry out daily activities with minimal assistance. Additionally, they need to meet certain health criteria, such as having enough healthy blood cells and organ function. Throughout the study, which will last up to four years, participants will undergo regular check-ups to monitor their health, the effectiveness of the treatment, and any side effects. It's important for potential participants to discuss any medical history or current health conditions with their doctor to see if they qualify for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age greater than or equal to 18 years old, male or female;
• • 2. Relapsed or refractory CNS-involved large b-cell lymphoma after at least first-line therapy, with an efficacy assessment of CR or PR after salvage therapy, and current stable efficacy status;
• • 3. Eastern Cooperative Oncology Group (ECOG) score of 0-2;
• • 4. Have a life expectancy of ≥ 12 weeks
• • 5. Use contraception
• 6. Have adequate bone marrow and organ function:
• • 1. Neutrophil count (anc) ≥1.0 x 109/L;
• • 2. Hemoglobin ≥ 8.0 g/dl;
• • 3. Platelet count ≥ 50 x 109/L;
• • 4. Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
• • 5. Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5 x ULN or ≤ 5 x ULN (in the presence of hepatic invasion);
• • 6. Creatinine clearance ≥40mL/min
• • 7. Lipase ≤ 1.5 x ULN
• Exclusion Criteria:
• • 1. Severe active central nervous system symptoms
• • 2. Prior chimeric antigen receptor cellular immunotherapy targeting cd19
• • 3. Known human immunodeficiency virus (hiv) infection or positive immunoassay;
• • 4. Live vaccination within 30 days prior to study drug administration;
• • 5. Active autoimmune disease requiring systemic therapy in the last 12 months
• • 6. Allergy to the study drug or history of severe allergic reactions
• • 7. Potential risk of malignant cardiac arrhythmia
• • 8. History of stroke or intracranial hemorrhage within 3 months prior to the date of administration of study medication
• • 9. Other malignant tumors presently or within 3 years prior to enrollment
• • 10. Conditions that, in the judgment of the investigator, would interfere with full participation in the study; pose a significant risk to the subject; or interfere with the interpretation of the study data
• • 11. Pregnant or lactating patients;