Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06876688

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beljing Tiantan Hospital, Capttal Medical, University, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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;

Treatment and study plan

Relma-cel Followed by Tislelizumab

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 14, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.