Can an immune booster outsmart brain lymphoma?
NCT ID NCT07764601
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This trial is testing whether adding an immunotherapy drug called penpulimab to a standard chemotherapy regimen can help people with primary central nervous system lymphoma, a rare type of brain cancer. Participants, who have not yet received treatment, are randomly assigned to receive either the standard chemo alone or the chemo plus penpulimab. The study aims to see if the combination improves the chance of staying free of disease for two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- penpulimab (an anti-PD-1 immunotherapy) added to a standard chemotherapy regimen (rituximab, methotrexate, cytarabine)
- What this could lead to
- If adding penpulimab works, it could improve how long people with this rare brain lymphoma stay free of disease, potentially offering a new standard of care.
- What could go wrong
- This is a relatively small, early-stage trial, and the added drug may increase side effects without improving outcomes. Results may not apply to all patients.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 58 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 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 to 80 years
- 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. Fully understands the study and voluntarily signs informed consent. 2. Age 18 to 80 years. 3. Treatment-naive, pathologically (immunophenotypically) confirmed PCNSL (per 2016 WHO classification). 4. Diffuse large B-cell lymphoma originating in the CNS without other organ involvement, confirmed by PET-CT or contrast-enhanced CT. 5. Expected survival more than 3 months. 6. Laboratory: creatinine clearance ≥50 mL/min (Cockcroft-Gault); INR ≤1.5 x ULN or aPTT ≤1.5 x ULN (INR 2-3 allowed if on warfarin); LVEF ≥50%. 7. GFR ≥60 mL/min. 8. Participants of childbearing potential must agree to use effective contraception during the study and for 30 days after the last dose. Exclusion Criteria: 1. Contraindication to any study drug. 2. Clinically significant liver disease, including viral or other hepatitis or cirrhosis (active HBV or active hepatitis C as defined). 3. HIV infection. 4. History of allergic disease, severe drug allergy, or known hypersensitivity to macromolecular protein preparations or any component of penpulimab. 5. Prior anti-PD-1/PD-L1/PD-L2, anti-CTLA-4 antibody, CAR-T, or any other agent targeting T-cell co-stimulation or checkpoint pathways. 6. Congestive heart failure (NYHA \>2); acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months. 7. Congenital long QT syndrome or QTcF \>480 ms. 8. Other malignancy within the past 5 years (except adequately treated in situ cervical carcinoma, basal cell skin carcinoma, in situ breast carcinoma, or a second primary cancer cured and recurrence-free for 5 years). 9. Pregnant or lactating women, or intending to become pregnant during the study. 10. History of clinically significant neurological or psychiatric disorder, or substance/drug abuse. 11. Clinically significant active infection.
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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
5 sites. 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 Nanjing Medical University
Nanjing, Jiangsu, China
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The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
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The First People's Hospital of Huai'an
Huai'an, Jiangsu, China
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Wuxi People's Hospital
Wuxi, Jiangsu, China
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Yixing People's Hospital
Yixing, Jiangsu, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug BL-M08D1 joins standard therapy in fight against aggressive lymphoma
- Can AI spot the lymphoma patients who Won't respond?
- Outpatient immunotherapy tested for hard-to-treat lymphomas
- Can an antibody drug boost standard chemotherapy against an aggressive blood cancer?
- A CAR-T therapy given by injection: can it help Hard-to-Treat lymphoma?
- New drug joins standard chemotherapy in fight against B-Cell lymphoma