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

March 10, 2025 updated by: Ruijin Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Not yet recruiting
        • Xuanwu Hospital Capital Medical University
        • Contact:
          • Wanling Sun
      • Beijing, China
        • Not yet recruiting
        • Beljing Tiantan Hospital, Capttal Medical, University
        • Contact:
          • Yuanbo Liu
      • Guangzhou, China
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Zhiming Li
      • Henan, China
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
          • Keshu Zhou
      • Shanghai, China
        • Recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Wenyan Yu
        • Principal Investigator:
          • Jianqing Mi
      • Wuhan, China
        • Not yet recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,
        • Contact:
          • Yi Xiao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
Relma-cel Followed by Tislelizumab
Drug: Relma-cel Followed by Tislelizumab
Enrolled patients with relapsed/refractory (R/R) CNSL will receive Relma-cel infusion, followed by treatment with Tislelizumab (200mg, IV, q4w, for 12 months) starting at 35 days post-infusion. BTK inhibitors will be used in combination as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate(CRR) at 3-month
Time Frame: 3 months post CAR-T infusion
Complete response rate at 3-month is defined as the incidence of subjects achieving complete response (CR) at 3-month after CAR-T infusion according to the Lugano Classification, as determined by study investigators.
3 months post CAR-T infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: 2 years post CAR-T infusion
PFS is defined as the time from the CAR-T infusion date to the date of disease progression or death from any cause.
2 years post CAR-T infusion
Overall Survival (OS)
Time Frame: 2 years post CAR-T infusion
OS is defined as the time from CAR-T infusion to the date of death from any cause.
2 years post CAR-T infusion
Objective remission rate (ORR) at 3-month
Time Frame: 3 months post CAR-T infusion
Objective remission rate (ORR) at 3-month is defined as the incidence of either a CR or a partial response (PR) at 3-month after CAR-T infusion per the Lugano Classification as determined by study investigators
3 months post CAR-T infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2023

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2028

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNSL-CART

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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