New cocktail of four drugs hopes to tackle tough lymphoma
NCT ID NCT07418190
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing a combination of four drugs (zanubrutinib, rituximab, lenalidomide, and tislelizumab) in 33 people with follicular lymphoma that has returned or not responded to at least two prior treatments. The goal is to see how many patients achieve a complete response after six cycles of therapy. Those who respond will continue on a maintenance regimen for up to a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- zanubrutinib, rituximab, lenalidomide, and tislelizumab
- What this could lead to
- If successful, this combination could offer a new treatment option for patients with follicular lymphoma that has come back or not responded to prior therapies.
- What could go wrong
- This is a small, early-phase trial (33 people) with no comparison group. The combination may cause significant side effects, and 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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 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 to 75 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: * Eligible participants must meet all of the following criteria: Provide written informed consent. Age ≥18 years . Histologically confirmed relapsed/refractory follicular lymphoma (R/R FL) . Received at least two prior lines of systemic therapy , including anti-CD20 monoclonal antibody therapy. ECOG performance status 0-1 . Measurable disease , with longest diameter \>1.5 cm . Estimated life expectancy (per investigator assessment) ≥18 weeks . Adverse events from prior anticancer therapy must have resolved to ≤ grade 1 (except alopecia and anorexia). Adequate hepatic function: Total bilirubin ≤1.5 × ULN ; for patients with documented Gilbert syndrome: total bilirubin ≤3 × ULN with predominantly indirect hyperbilirubinemia. AST and ALT ≤3 × ULN . Adequate hematologic function: ANC ≥1.5 × 10⁹/L (≥1,500/µL) Platelets ≥75,000/µL , with no platelet transfusion within 14 days prior to first dosing on Cycle 1 Day 1 Hemoglobin ≥10.0 g/dL (6.2 mmol/L), with no blood transfusion within 21 days prior to first dosing on Cycle 1 Day 1 Adequate renal function: serum creatinine ≤1.5 × ULN , or creatinine clearance ≥50 mL/min calculated by the Cockcroft-Gault formula (see Appendix 14), for patients in whom serum creatinine may not adequately reflect renal function per investigator judgment. For women of childbearing potential: negative serum pregnancy test within 7 days before study treatment; postmenopausal women (non-treatment-related amenorrhea ≥12 months) or surgically sterile women (no ovaries and/or uterus) are exempt. Women of childbearing potential must agree to abstinence (avoid heterosexual intercourse) or to use effective contraception. For men: agree to abstinence (avoid heterosexual intercourse) or to use effective contraception. Exclusion Criteria: * Participants meeting any of the following will be excluded: 1. Unable to comply with protocol-required hospitalization and restrictions. 2. Active infection or latent tuberculosis infection. 3. History of severe hypersensitivity to drugs of the same class. 4. Current central nervous system involvement. 5. Pregnant or breastfeeding women. 6. Uncontrolled comorbidities (e.g., cardiac disease, immune disorders); myocardial infarction, unstable arrhythmia, or unstable angina within the past 6 months. 7. Illicit drug use or alcohol abuse within 12 months prior to screening, per investigator judgment. 8. Any other disease, metabolic disorder, physical examination finding, or clinical laboratory abnormality that reasonably suggests a contraindication to the investigational products. 9. The investigator should review vaccination status of potential participants and, prior to study initiation, follow local disease control and prevention guidelines for adult immunization with non-live vaccines aimed at preventing infectious diseases. 10. Any psychiatric or cognitive disorder that may limit understanding/execution of informed consent or protocol compliance. 11. Pregnant or breastfeeding women, or women/men (or male partners) planning pregnancy during the study period. 12. Any other condition deemed by the investigator to make the participant unsuitable for the trial. * Cases to Be Excluded From Statistical Analysis (per protocol) Participants already enrolled who meet any of the following will be treated as excluded cases in statistical analyses: Post-enrollment discovery of non-fulfillment of eligibility criteria. Prior exposure to zanubrutinib or other BTK inhibitors. Intolerable toxicity after taking zanubrutinib or other BTK inhibitors. Received fewer than two consecutive administrations after enrollment such that objective efficacy cannot be assessed (adverse events may still be assessable). Protocol violations. Prior hematopoietic stem cell transplantation.
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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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Jiangsu Province Hospital
RECRUITINGNanjing, Jiangsu, 210000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New immune cell combo tackles tough lymphoma
- Off-the-Shelf CAR t cells take on tough lymphomas
- New hope for lymphoma patients: zanubrutinib combo enters phase 3 trial
- New hope for hard-to-treat lymphoma: targeted drug combo tested in large trial