Pomalidomide, anti–PD‑1 antibody, and selinexor for relapsed/refractory primary CNS 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

This trial tests whether combining pomalidomide, a PD‑1 blocking antibody, and selinexor can help adults with relapsed or refractory primary central nervous system diffuse large B‑cell lymphoma.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Tongren Hospital (other)
• Drugs / interventions: methotrexate, chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07523737 on ClinicalTrials.gov

What this trial studies

This prospective, multicenter, single‑arm phase II trial gives a combination of pomalidomide, an anti–PD‑1 monoclonal antibody, and the XPO1 inhibitor selinexor to adults with relapsed or refractory PCNSL‑DLBCL after prior high‑dose methotrexate and/or BTK inhibitors. The study primarily measures tumor response rate and safety, with scheduled brain MRIs, neurologic exams, laboratory monitoring, and adverse event reporting. Eligible participants are 18–75 years old with ECOG 0–4 and adequate hematologic, renal, and hepatic function. Treatment is administered per protocol with ongoing imaging and clinical follow‑up to capture duration of response and survival outcomes.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically confirmed relapsed or refractory primary CNS diffuse large B‑cell lymphoma who progressed after high‑dose methotrexate and/or BTK inhibitors, have ECOG 0–4, and meet baseline blood and organ‑function requirements are ideal candidates.

Not a fit: Patients who are pregnant or breastfeeding, have another active cancer needing treatment, severe organ dysfunction, or known hypersensitivity to the study drugs are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this combination could increase response rates and extend survival for people with relapsed/refractory PCNSL while providing a potentially tolerable outpatient regimen.

How similar studies have performed: Smaller studies and case reports have shown activity for PD‑1 inhibitors or immunomodulatory drugs like pomalidomide in PCNSL, but combining pomalidomide, PD‑1 blockade, and selinexor is novel and not yet proven in larger trials.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tongren Hospital, Capital Medical University — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Liang Wang, M.D. — Beijing Tongren Hospital
• Study coordinator: Liang Wang, M.D.

Conditions: Primary Central Nervous System Lymphoma, Diffuse Large B Cell Lymphoma, diffuse large b cell lymphoma, primary central nervous system lymphoma, pomalidomide, PD-1 inhibitor, XPO1 inhibitor, selinexor