New drug cocktail aims to tame deadly immune storm in lymphoma
NCT ID NCT07270835
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of two drugs, zanubrutinib and rituximab, for people with B-cell lymphoma who develop a severe immune overreaction called hemophagocytic lymphohistiocytosis (HLH). The trial will enroll 40 participants and aims to see how well the treatment controls HLH after 4 weeks. The approach adds targeted therapy to standard care, potentially offering a new way to manage this dangerous complication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- zanubrutinib and rituximab
- What this could lead to
- If successful, this combination could offer a new treatment option for a rare and life-threatening complication of B-cell lymphoma.
- What could go wrong
- This is a small, early-phase trial with only 40 participants. The treatment may not work for everyone, and side effects are possible.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Aug 2027
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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14 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: * According to the diagnostic criteria of HLH-04, the patients meet the diagnostic criteria of HLH; * HLH patients with definite or highly suspected evidence of B-cell lymphoma; Or HLH patients whose bone marrow flow cytometry show an increased proportion of CD20-positive B cells; * Age of 14-80 years old, both sexes; * Predicted survival beyond 1 month; * Baseline serum creatinine ≤1.5 times ULN; Fibrinogen could be corrected to ≥0.6g/L by infusion; * Negative serum HIV antibody; Either negative for HCV antibodies or positive for HCV antibodies but negative for HCV RNA. HBV surface antigen and HBV core antibody were negative. If any of the above was positive, HBV DNA titer in peripheral blood should be tested, and the titer was less than 1×10\^3 copies /ml; * Left ventricular ejection fraction (LVEF) ≥50% measured by echocardiography; * The patient have no serious and uncontrollable infections, such as pulmonary infection, intestinal infection, and sepsis; * Women of childbearing age must be confirmed to be not pregnant by pregnancy test and willing to take effective measures to prevent pregnancy during the study period and ≥12 months after the last dose; Pregnant and lactating women cannot participate; All male subjects took contraceptive measures during the trial and ≥3 months after the last dose; * Patients should be able to sign informed consent. Exclusion Criteria: * Patients with known severe allergy to rituximab, zanubrutinib, or other BTK inhibitors; * Severe active infections (including bacterial, viral or fungal infections) or uncontrolled co-infections; * Severe organ dysfunction including NYHA class III-IV heart failure or severe arrhythmia; Liver function: ALT or AST \>5 times the upper limit, or severe cirrhosis; Renal function: CrCl \<30 mL/min or severe renal insufficiency; * Combined with other malignant tumors and the expected survival time was less than 3 months; * Have received other experimental drugs and had not completed the drug washout period; * Pregnant or lactating women, or unwilling to use effective contraception; * any condition that would not be suitable for participation in the study or that might affect adherence, follow-up, or safety assessment, as judged by the investigator.
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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 Soochow University
RECRUITINGSuzhou, Jiangsu, China
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