Actively Recruiting
Relma-cel Followed by Tislelizumab for the Treatment of Relapsed/Refractory CNS Large B-Cell Lymphoma
Led by Ruijin Hospital · Updated on 2025-03-14
30
Participants Needed
6
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Relma-cel Followed by Tislelizumab for the Treatment of Relapsed/Refractory CNS Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Relapsed or refractory CNS-involved large B-cell lymphoma after at least first-line therapy, with complete or partial response after salvage therapy and stable disease status
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
- Life expectancy of at least 12 weeks
- Use of contraception
- Adequate bone marrow and organ function including:
- Neutrophil count ≥ 1.0 x 10^9/L
- Hemoglobin ≥ 8.0 g/dL
- Platelet count ≥ 50 x 10^9/L
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT/AST ≤ 2.5 times ULN or ≤ 5 times ULN if hepatic invasion present
- Creatinine clearance ≥ 40 mL/min
- Lipase ≤ 1.5 times ULN
You will not qualify if you...
- Severe active central nervous system symptoms
- Prior chimeric antigen receptor (CAR) cellular immunotherapy targeting CD19
- Known HIV infection or positive HIV immunoassay
- Live vaccination within 30 days before study drug administration
- Active autoimmune disease requiring systemic therapy within the last 12 months
- Allergy to study drugs or history of severe allergic reactions
- Potential risk of malignant cardiac arrhythmia
- History of stroke or intracranial hemorrhage within 3 months prior to study drug administration
- Other malignant tumors currently or within 3 years prior to enrollment
- Conditions interfering with full participation, posing significant risk, or affecting study data interpretation
- Pregnancy or lactation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Beljing Tiantan Hospital, Capttal Medical, University
Beijing, China
Not Yet Recruiting
2
Xuanwu Hospital Capital Medical University
Beijing, China
Not Yet Recruiting
3
Sun Yat-Sen University Cancer Center
Guangzhou, China
Not Yet Recruiting
4
Henan Cancer Hospital
Henan, China
Not Yet Recruiting
5
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
6
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,
Wuhan, China
Not Yet Recruiting
Research Team
W
Wenyan Yu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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