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Recruiting Phase 2

Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma

NCT07523737 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2026-04-01
Last updated
2026-04-15

Condition(s) studied

Primary Central Nervous System Lymphoma (PCNSL)Diffuse Large B Cell Lymphoma (DLBCL)

Investigational drug(s) / intervention(s)

Pomalidomide →PD-1 / PD-L1 monoclonal antibodyXPO1 inhibitor →

Pomalidomide: 4 mg on days 1-14, every 3 weeks (q3w), for a total of 6 cycles

PD-1 / PD-L1 monoclonal antibody: tislelizumab 200 mg on day 1, q3w, for a total of 6 cycles

XPO1 inhibitor: Selinexor: 60 mg on days 1, 8, and 15, q3w, for a total of 6 cycles

Study summary

Primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL) is a highly aggressive malignancy accounting for over 80% of primary CNS lymphomas, with an annual incidence of 0.4-0.6 per 100,000 people globally and a rising trend in immunocompetent patients. First-line high-dose methotrexate-based chemotherapy causes severe toxicities and nearly 50% of patients relapse within 1-2 years, developing relapsed/refractory (R/R) disease.

Treatment options for R/R PCNSL are scarce, with low response rates, median survival of only 3-6 months, and 5-year survival below 5%. The blood-brain barrier and tumor heterogeneity further worsen outcomes. This prospective, multicenter, single-arm phase II study evaluates the efficacy and safety of pomalidomide, PD-1 inhibitor, and selinexor (PPS) in R/R PCNSL, aiming to provide a new effective treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Histologically confirmed primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL). * Disease progression or relapse after prior treatment with high-dose methotrexate and/or BTK inhibitors. * Age between 18 and 75 years. * ECOG performance status score 0-4. * Expected overall survival \> 3 months. * No known hypersensitivity to any study drug. * White blood cell count ≥ 3×10⁹/L; absolute neutrophil count ≥ 1.0×10⁹/L; platelet count ≥ 50×10⁹/L. * Serum creatinine ≤ 1.5 mg/dL; creatinine clearance ≥ 50 mL/min. * ALT and AST ≤ 3× upper limit of normal (ULN); total bilirubin ≤ 2× ULN. * Signed written informed consent. Exclusion Criteria: * Presence of another malignant tumor requiring active pharmacological or surgical intervention at present; * Female patients who are pregnant or breastfeeding; * Patients (male or female) of reproductive potential who are unwilling to use or fail to use effective contraceptive measures; * Known hypersensitivity to any study drug or any excipient ingredients of these products; * Active infection (determined by the investigator); * History of immunodeficiency, including positive HIV status, other acquired or congenital immunodeficiency disorders, or history of organ transplantation; * Documented history of neurological or psychiatric disorders, including epilepsy or dementia; * Documented history of autoimmune diseases (except Hashimoto's thyroiditis or thyroid dysfunction); * Any severe comorbidity that, in the investigator's judgment, would compromise patient safety or interfere with the completion of the study.

Primary outcome measure(s)

  • best overall response rate (ORR) as of 6 cycles of PPS — From the day of initiation of PPS treatment to 3 weeks after 6 cycles of PPS treatment (the length of each cycle is 3 weeks)
    Overall response rate means sum of complete response rate and partial response rate

Trial sites (1)

FacilityCityRegionStatus
Beijing Tongren Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07523737 on ClinicalTrials.gov ↗ ← All trials in China