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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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;

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06876688
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ruijin Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

CNS Lymphoma
Arms & Interventions

Arms

Experimental: intervention group

Relma-cel Followed by Tislelizumab

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, China

Status

Not yet recruiting

Address

Beljing Tiantan Hospital, Capttal Medical, University

Beijing, ,

Site Contact

Yuanbo Liu

[email protected]

+86 13564230293

Beijing, China

Status

Not yet recruiting

Address

Xuanwu Hospital Capital Medical University

Beijing, ,

Site Contact

Wanling Sun

[email protected]

+86 13564230293

Sun Yat-Sen University Cancer Center, Guangzhou, China

Status

Not yet recruiting

Address

Sun Yat-Sen University Cancer Center

Guangzhou, ,

Site Contact

Zhiming Li

[email protected]

+86 13564230293

Henan Cancer Hospital, Henan, China

Status

Not yet recruiting

Address

Henan Cancer Hospital

Henan, ,

Site Contact

Keshu Zhou

[email protected]

+86 13564230293

Shanghai, China

Status

Recruiting

Address

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, ,

Site Contact

Wenyan Yu

[email protected]

+86 13564230293

Wuhan, China

Status

Not yet recruiting

Address

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

Wuhan, ,

Site Contact

Yi Xiao

[email protected]

+86 13564230293

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