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

Relmacabtagene Autoleucel Injection Followed by Tislelizumab for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma Involved in the Central Nervous System

This study is testing a new treatment combining a cellular therapy and an immunotherapy for people with relapsed central nervous system large B-cell lymphoma to see if it helps them feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Drugs / interventions: chimeric antigen receptor, immunotherapy, Tislelizumab
• Locations: 6 sites (Beijing and 5 other locations)
• Trial ID: NCT06876688 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory CNS large B-cell lymphoma after at least one prior therapy.

Not a fit: Patients with severe active CNS symptoms or those who have previously received specific CAR T-cell therapies targeting CD19 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could provide a new effective option for patients with difficult-to-treat CNS lymphoma.

How similar studies have performed: While there have been studies on CAR T-cell therapies and immunotherapies for lymphoma, this specific combination approach is novel and has not been extensively tested.

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;

Where this trial is running

Beijing and 5 other locations

• 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)
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, — Wuhan, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Wenyan Yu

Conditions CNS Lymphoma