Treatment of relapsed CNS large B-cell lymphoma with Relma-cel and Tislelizumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of Relma-cel, a cellular therapy, followed by Tislelizumab, an immunotherapy, in patients with relapsed or refractory central nervous system large B-cell lymphoma. Participants will receive an infusion of Relma-cel, and then start Tislelizumab treatment 35 days later, with the potential addition of Bruton's tyrosine kinase inhibitors as needed. The study will monitor drug safety, disease status, survival, and pharmacokinetics over a follow-up period of four years.

Why it matters

Who can join: the full rules

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;

Where it's running

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, China Recruiting
• Beljing Tiantan Hospital, Capttal Medical, University
  Beijing, China Not yet recruiting
• Xuanwu Hospital Capital Medical University
  Beijing, China Not yet recruiting
• Sun Yat-Sen University Cancer Center
  Guangzhou, China Not yet recruiting
• Henan Cancer Hospital
  Henan, China Not yet recruiting
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,
  Wuhan, China Not yet recruiting

Study contacts

• Study coordinator: Wenyan Yu
• Email: 1152227516@qq.com
• Phone: +86 13564230293

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.