NCT06876688 Relma-cel Followed by Tislelizumab for the Treatment of Relapsed/Refractory CNS Large B-Cell Lymphoma
| NCT ID | NCT06876688 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ruijin Hospital |
| Condition | CNS Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-11-30 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2023-11-30 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to evaluate the efficacy and safety of Relma-cel in the treatment of central nervous system lymphoma (CNSL), as well as its pharmacokinetic characteristics. Enrolled patients with relapsed/refractory (R/R) CNSL will receive Relma-cel infusion, followed by Tislelizumab treatment (200mg, IV, q4w, for 12 months) starting on day 35 after infusion. Bruton's tyrosine kinase (BTK) inhibitors will be used in combination as needed. The follow-up period will last for 4 years, monitoring drug safety, disease status, survival, and the pharmacokinetic characteristics of Relma-cel.
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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06876688 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CNS Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06876688 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06876688 currently recruiting?
Yes, NCT06876688 is actively recruiting participants. Contact the research team at 1152227516@qq.com for enrollment information.
Where is the NCT06876688 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Guangzhou, China, Henan, China and 2 additional locations.
Who is sponsoring the NCT06876688 clinical trial?
NCT06876688 is sponsored by Ruijin Hospital. The trial plans to enroll 30 participants.