Actively Recruiting
Relmacabtagene Autoleucel Injection Followed by Tislelizumab for Relapsed/Refractory Large B-Cell Lymphoma Involving the Central Nervous System
Led by Ruijin Hospital · Updated on 2025-03-14
30
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Relma-cel followed by Tislelizumab in treating people with relapsed or refractory central nervous system large B-cell lymphoma (CNSL). The study also looks at how the body processes Relma-cel. This phase 2 trial includes patients whose lymphoma has returned or not responded after prior treatments. Participants will receive an infusion of Relma-cel, then start Tislelizumab treatment (200 mg given intravenously every 4 weeks) beginning 35 days after the infusion and continuing for 12 months. Bruton's tyrosine kinase (BTK) inhibitors may be added if needed. The study focuses on one treatment group receiving this combination. During the study, participants will be monitored for drug safety, disease status, survival, and how Relma-cel behaves in the body. The main measure is the complete response rate three months after the Relma-cel infusion. Secondary outcomes include progression-free survival, overall survival, and objective remission rate assessed up to two years post-infusion. Follow-up will continue for four years to track long-term results.
CONDITIONS
Brief 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
- Achieved complete or partial response after salvage therapy and currently stable
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2
- Life expectancy of at least 12 weeks
- Use of contraception during the study
- 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 x ULN or ≤ 5 x ULN if liver involvement
- Creatinine clearance ≥ 40 mL/min
- Lipase ≤ 1.5 x ULN
You will not qualify if you...
- Severe active central nervous system symptoms
- Previous CAR T-cell therapy targeting CD19
- Known HIV infection or positive HIV test
- Live vaccination within 30 days before study drug
- Active autoimmune disease requiring systemic treatment within past 12 months
- Allergy to study drugs or history of severe allergic reactions
- High risk of malignant cardiac arrhythmia
- Stroke or intracranial hemorrhage within 3 months before treatment
- Other active malignancies within 3 years prior to enrollment
- Any condition interfering with participation or study data interpretation
- Pregnant or breastfeeding individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants receive a Relma-cel infusion followed by Tislelizumab treatment starting 35 days after infusion. Tislelizumab is given intravenously every 4 weeks for up to 12 months. BTK inhibitors may be used in combination as needed.
Initial infusion visit followed by visits every 4 weeks for Tislelizumab administration
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
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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