Status:
RECRUITING
Relma-cel Followed by Tislelizumab for the Treatment of Relapsed/Refractory CNS Large B-Cell Lymphoma
Lead Sponsor:
Ruijin Hospital
Conditions:
CNS Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 rela...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 years old, male or female;
- 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;
- Eastern Cooperative Oncology Group (ECOG) score of 0-2;
- Have a life expectancy of ≥ 12 weeks
- Use contraception
- Have adequate bone marrow and organ function:
- Neutrophil count (anc) ≥1.0 x 109/L;
- Hemoglobin ≥ 8.0 g/dl;
- Platelet count ≥ 50 x 109/L;
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5 x ULN or ≤ 5 x ULN (in the presence of hepatic invasion);
- Creatinine clearance ≥40mL/min
- Lipase ≤ 1.5 x ULN
Exclusion
- Severe active central nervous system symptoms
- Prior chimeric antigen receptor cellular immunotherapy targeting cd19
- Known human immunodeficiency virus (hiv) infection or positive immunoassay;
- Live vaccination within 30 days prior to study drug administration;
- Active autoimmune disease requiring systemic therapy in the last 12 months
- Allergy to the study drug or history of severe allergic reactions
- Potential risk of malignant cardiac arrhythmia
- History of stroke or intracranial hemorrhage within 3 months prior to the date of administration of study medication
- Other malignant tumors presently or within 3 years prior to enrollment
- 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
- Pregnant or lactating patients;
Key Trial Info
Start Date :
November 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06876688
Start Date
November 30 2023
End Date
November 30 2028
Last Update
March 14 2025
Active Locations (6)
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1
Beljing Tiantan Hospital, Capttal Medical, University
Beijing, China
2
Xuanwu Hospital Capital Medical University
Beijing, China
3
Sun Yat-Sen University Cancer Center
Guangzhou, China
4
Henan Cancer Hospital
Henan, China