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

Phase 2

Recruiting

• Conditions: CNS Lymphoma
• Interventions: Drug: Relma-cel Followed by Tislelizumab

• Registration Number: NCT06876688
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-30
• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Study First Posted: 2025-03-14
• Last Update Posted: 2025-03-14
• Primary Completion: 2028-11-30
• Study Completion: 2028-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intervention group	Relma-cel Followed by Tislelizumab	Relma-cel Followed by Tislelizumab

Primary Outcome Measures

Name	Time	Method
Complete response rate(CRR) at 3-month	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 Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	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.
Overall Survival (OS)	2 years post CAR-T infusion	OS is defined as the time from CAR-T infusion to the date of death from any cause.
Objective remission rate (ORR) at 3-month	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

Trial Locations

Locations (6)

Beljing Tiantan Hospital, Capttal Medical, University; 🇨🇳 Beijing, China

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, China

Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,; 🇨🇳 Wuhan, China

Henan Cancer Hospital; 🇨🇳 Henan, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China