NCT07523737RecruitingPhase 2

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

Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Study

Source: ClinicalTrials.gov · Last updated 15 Apr 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 43 (estimated)
First submitted: 6 Apr 2026
Start date: 1 Apr 2026
Primary completion date: 31 Mar 2028
Lead sponsor: Beijing Tongren Hospital
Diseases: Diffuse large B-cell lymphoma
NCT number: NCT07523737

What you commit to

Study type: Interventional · Phase 2
Planned participants: 43
From 1 Apr 2026 to the primary completion date, 31 Mar 2028
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

Presence of another malignant tumor requiring active pharmacological or surgical intervention at present;
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);

Other

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;
Any severe comorbidity that, in the investigator's judgment, would compromise patient safety or interfere with the completion of the study.

Who the study is looking for

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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Beijing Tongren Hospital, Capital Medical University Coordinator of this site? Confirm its status	Beijing	China	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.