Can a Four-Pronged attack beat brain lymphoma?
NCT ID NCT07749365
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial is testing whether combining a short course of focused radiation with three drugs—GM-CSF, pomalidomide, and glofitamab—can effectively treat newly diagnosed primary central nervous system diffuse large B-cell lymphoma (PCNSL), a rare and aggressive cancer of the brain or spinal cord. The study will enroll about 53 adults with this condition to see how many achieve a complete response, meaning no detectable cancer remains. The goal is to find a more powerful first-line treatment that could improve outcomes for patients with this challenging disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of hypofractionated radiotherapy, GM-CSF, pomalidomide, and glofitamab
- What this could lead to
- If successful, this combination could offer a more effective first-line treatment for primary central nervous system lymphoma, potentially improving complete response rates and long-term outcomes.
- What could go wrong
- This is a phase II trial with a relatively small number of participants, so results may not be definitive. The combination may cause significant side effects, and the added benefit over standard therapy is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 53 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Written informed consent must be obtained before any study-related procedures. 2. Age ≥18 years, regardless of sex, with an expected survival time \>3 months. 3. Histologically confirmed diffuse large B-cell lymphoma (DLBCL). 4. Newly diagnosed patients with primary central nervous system diffuse large B-cell lymphoma (PCNSL). 5. No previous treatment with bispecific antibodies. 6. B-cell non-Hodgkin lymphoma with at least one measurable lesion according to RECIST 1.1 criteria, or detectable abnormal monoclonal B cells by cerebrospinal fluid (CSF) flow cytometry. 7. Adequate organ function meeting the following laboratory criteria: * Total bilirubin ≤1.5 × upper limit of normal (ULN); * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN; * Serum creatinine ≤1.5 × ULN and creatinine clearance ≥60 mL/min (calculated using the Cockcroft-Gault formula); * Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN. 8. Women of childbearing potential must have a negative urine or serum pregnancy test within 3 days before the first dose of study treatment (Cycle 1 Day 1). If urine pregnancy testing cannot confirm a negative result, a serum pregnancy test is required. Women of non-childbearing potential are defined as those who are postmenopausal for ≥1 year or have undergone surgical sterilization or hysterectomy. 9. All participants with reproductive potential (male or female) must use highly effective contraception with a failure rate \<1% per year during treatment and for 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy). Exclusion Criteria: 1. Loss of CD20 expression in B-cell non-Hodgkin lymphoma. 2. Active acute or chronic hepatitis B or hepatitis C infection, including: * HBV DNA \>2,000 IU/mL or \>10⁴ copies/mL without willingness to receive regular antiviral therapy; * HCV RNA \>10³ copies/mL; * Concurrent positivity for HBsAg and anti-HCV antibody. 3. Receipt of anti-hematologic malignancy therapy within 2 weeks or within 5 pharmacokinetic half-lives before treatment initiation, whichever is longer. 4. Inadequate bone marrow reserve, defined as platelet count \<30 ×10⁹/L or absolute neutrophil count \<1.0 ×10⁹/L. 5. Clinically significant pulmonary diseases, including: * Chronic obstructive pulmonary disease (COPD) with FEV1 \<50% of predicted value; * Moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any severity. 6. Uncontrolled hypertension despite optimal medical management (systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg), history of hypertensive crisis, or hypertensive encephalopathy. 7. Symptomatic congestive heart failure (NYHA class II-IV), symptomatic or poorly controlled arrhythmias, congenital long QT syndrome, or corrected QT interval (QTc) \>500 ms (Fridericia correction). 8. Receipt of hypofractionated radiotherapy within 4 weeks before the first treatment. Patients receiving radiotherapy \>4 weeks before enrollment must have no ongoing radiation-related toxicities, no requirement for corticosteroids, and no evidence of radiation pneumonitis, hepatitis, enteritis, or other radiation-related complications. 9. Difficulty swallowing oral medications. 10. History or presence of pulmonary fibrosis, interstitial lung disease, pneumoconiosis, drug-induced pneumonitis, or severe pulmonary dysfunction. 11. HIV infection (positive HIV-1/2 antibody) or known syphilis infection. 12. Presence of unhealed wounds, fractures, gastric or duodenal ulcers, persistent positive fecal occult blood test, ulcerative colitis, or other conditions associated with risk of gastrointestinal bleeding or perforation as determined by the investigator. 13. Active or uncontrolled severe infection, including severe infection requiring hospitalization due to infection, bacteremia, or severe pneumonia within 4 weeks before the first dose. 14. Major surgery or significant traumatic injury within 4 weeks before the first dose. 15. Use of traditional Chinese medicine with antitumor indications within 2 weeks before the first dose. 16. Known hypersensitivity to any component of bispecific antibodies or GM-CSF preparations. 17. Receipt of treatment in another clinical trial within 4 weeks before the first dose. 18. Pregnant or breastfeeding women. 19. Active autoimmune disease or history of autoimmune disease, including but not limited to autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, and nephritis. Patients requiring medical intervention with bronchodilators for asthma are excluded. The following conditions are permitted: vitiligo, psoriasis, alopecia, or controlled type I diabetes not requiring systemic treatment, and hypothyroidism controlled with hormone replacement therapy. 20. Any other acute or chronic disease, psychiatric condition, or abnormal laboratory finding that may: * Increase the risk associated with study participation or administration of study treatment; * Interfere with interpretation of study results; * Render the patient unsuitable for participation according to the investigator's judgment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Xiamen University
RECRUITINGXiamen, Fujian, 361003, China
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- Can a reshaped chemo combo tame lymphoma with fewer side effects?