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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2028-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Relmacabtagene Autoleucel as First-Line Therapy for High-Risk Large B-Cell Lymphoma

NCT05590221

B-cell Lymphoma

RECRUITING PHASE2

Relmacabtagene Autoleucel in Patients With LBCL

NCT06142175

Large B-cell Lymphoma

RECRUITING

A Study of Secondary Infusion of Relmacabtagene Autoleucel Injection for Relapsed or Refractory B-cell Lymphoma

NCT05814848

Relapsed or Refractory B-cell Lymphoma

NOT_YET_RECRUITING PHASE4

Relmacabtagene Autoleucel Combined With Autologous Hematopoietic Stem Cell Transplantation, Orelabrutinib, and Sintilimab for Primary Central Nervous System Lymphoma

NCT07198464

Primary Central Nervous System Lymphoma (PCNSL)

NOT_YET_RECRUITING NA

Relmacabtagene Autoleucel in Hematologic Malignancies

NCT06142188

Lymphoma, B-Cell Large B-cell Lymphoma Follicular Lymphoma

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

CNS Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intervention group

Relma-cel Followed by Tislelizumab

Group Type EXPERIMENTAL

Relma-cel Followed by Tislelizumab

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No