NCT06876688

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
31mo left

Started Nov 2023

Longer than P75 for phase_2

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Nov 2023Nov 2028

Study Start

First participant enrolled

November 30, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

5 years

First QC Date

March 10, 2025

Last Update Submit

March 10, 2025

Conditions

CNS Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Complete response rate(CRR) at 3-month

    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 Outcomes (3)

  • Progression-Free Survival (PFS)

    2 years post CAR-T infusion

  • Overall Survival (OS)

    2 years post CAR-T infusion

  • Objective remission rate (ORR) at 3-month

    3 months post CAR-T infusion

Study Arms (1)

intervention group

EXPERIMENTAL

Relma-cel Followed by Tislelizumab

Drug: Relma-cel Followed by Tislelizumab

Interventions

Relma-cel Followed by TislelizumabDRUG

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.

intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

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

Central Study Contacts

Wenyan Yu

CONTACT

+86 135642302931152227516@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 14, 2025

Study Start

November 30, 2023

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2028

Last Updated

March 14, 2025

Record last verified: 2025-03

Locations

CN(6)