Relma-cel Followed by Tislelizumab for the Treatment of Relapsed/Refractory CNS Large B-Cell Lymphoma

Last updated: March 10, 2025
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Treatment

Relma-cel Followed by Tislelizumab

Clinical Study ID

NCT06876688
CNSL-CART
  • Ages > 18
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

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-linetherapy, with an efficacy assessment of CR or PR after salvage therapy, and currentstable 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:

  7. Neutrophil count (anc) ≥1.0 x 109/L;

  8. Hemoglobin ≥ 8.0 g/dl;

  9. Platelet count ≥ 50 x 109/L;

  10. Total bilirubin ≤ 1.5 × upper limit of normal (ULN)

  11. Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5 x ULN or ≤ 5 x ULN (in the presence of hepatic invasion);

  12. Creatinine clearance ≥40mL/min

  13. Lipase ≤ 1.5 x ULN

Exclusion

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 ofadministration 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 fullparticipation in the study; pose a significant risk to the subject; or interferewith the interpretation of the study data

  11. Pregnant or lactating patients;

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Relma-cel Followed by Tislelizumab
Phase: 2
Study Start date:
November 30, 2023
Estimated Completion Date:
November 30, 2028

Connect with a study center

  • Beljing Tiantan Hospital, Capttal Medical, University

    Beijing,
    China

    Site Not Available

  • Xuanwu Hospital Capital Medical University

    Beijing,
    China

    Site Not Available

  • Sun Yat-Sen University Cancer Center

    Guangzhou,
    China

    Site Not Available

  • Henan Cancer Hospital

    Henan,
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai,
    China

    Active - Recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,

    Wuhan,
    China

    Site Not Available

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