CNS Lymphoma
Conditions
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.
Interventions
DRUGRelma-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.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactWenyan Yu
Outcome results
None listed