Can two immune boosters outsmart follicular lymphoma without chemo?
NCT ID NCT07731789
First seen Jul 28, 2026 · Last updated Sep 15, 2026 · Updated 3 times
Summary
This phase II trial is testing whether combining two lab-made antibodies, tafasitamab and rituximab, can help people with newly diagnosed follicular lymphoma achieve complete remission. Both antibodies are designed to help the immune system recognize and attack cancer cells. The study enrolls 30 adults with grade 1, 2, or 3a follicular lymphoma who need treatment. Researchers will measure how many patients have no signs of cancer after one year and track any side effects.
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 two monoclonal antibodies: tafasitamab and rituximab
- What this could lead to
- If successful, this combination could offer a more effective first-line treatment for follicular lymphoma, potentially leading to higher remission rates without chemotherapy.
- What could go wrong
- This is an early-phase trial with only 30 participants, so results may not apply broadly. Side effects from monoclonal antibodies can include infusion reactions and increased infection risk.
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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2032
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: * Age ≥ 18 years old * Patients must have histologic confirmation of follicular lymphoma (FL) (grade 1, 2, and 3A or classic follicular lymphoma) * Meeting any one of the following criteria for therapy initiation: * Involvement of ≥ 3 nodal sites, each with diameter of ≥ 3 cm. * Any nodal or extranodal tumor mass with a diameter of ≥ 7 cm. * B symptoms (fever ≥ 38 degrees Celsius of unclear etiology, night sweats, weight loss \> 10% within the prior 6 months) attributed to FL. * Risk of local compressive symptoms that may result in organ compromise. * Splenomegaly with the inferior margin below the umbilical line or splenic lesion without splenomegaly. * Significant cytopenia (absolute neutrophil count \< 1500/mm3, platelets \< 100,000/uL, hemoglobin \< 10 g/dL) * Leukemia (\> 5,0000/uL circulating lymphocytes) * Pleural effusion or ascites attributed to lymphoma * Have measurable nodal disease, including at least 1 disease site measuring at least 1.5 cm in longest dimension on CT or fludeoxyglucose (FDG)-PET, or a FDG-avid extranodal measurable site measuring at least 1.0 cm in longest dimension. Measurable disease also includes spleen size more than 13 cm in vertical length * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Absolute neutrophil count ≥ 1500/mm\^3 (unless due to lymphoma involvement of the bone marrow or spleen) * Platelets ≥ 75,000/mm\^3 (unless due to bone marrow involvement by lymphoma) * Hemoglobin ≥ 8 g/dL (unless due to bone marrow involvement by lymphoma) * Total bilirubin ≤ 2.0 mg/dL, except for patients with documented lymphoma involvement of liver or with a known history of Gilbert's disease * Alkaline phosphatase/aspartate aminotransferase (AST)/(serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3 × institutional upper limit of normal, except for patients with documented liver involvement * Creatinine clearance ≥ 30 ml/min * Fertile male and women of child bearing potential (WOCBP) patients must be willing to use highly effective contraceptive methods from study recruitment to at least 6 months after the last dose of study treatment * Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: * FL grade 3B or transformed FL * Patients receiving any other investigational agents * Patients with known central nervous system involvement of lymphoma * History of a second primary malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. Malignancies treated curatively or at low-risk of progressing at the judgment of the primary investigator (PI) may be included * Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection at study enrollment * Uncontrolled intercurrent illness such as: history of myocardial infarction (MI) in the last 6 months, congestive heart failure New York Heart Association (NYHA) Class III-IV, uncontrolled or symptomatic arrhythmia, stroke in last 6 months, liver cirrhosis, and autoimmune disorder requiring immunosuppression or long-term corticosteroids (\> 10 mg daily prednisone equivalent) * Prior use of any monoclonal antibody within 4 weeks before the first administration * Breastfeeding or pregnant women * Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody are eligible if the corresponding polymerase chain reaction (PCR) test is negative prior to enrollment. Hepatitis B core antibody (+) patients without evidence of HBsAg or Hep B PCR (+) are eligible with appropriate Hepatitis B reactivation prophylaxis as per institutional guidelines * History of human immunodeficiency virus (HIV) infection uncles the viral load is undetectable and CD4 count is at least 400 * History or evidence of rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption * Major surgery (excluding lymph node biopsy) within 28 days prior to signing the informed consent form (ICF) unless the participant is recovered at the time of signing the ICF * Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of cycle 1 * Administration of a live vaccine within 28 days prior to the start of study treatment (cycle 1 day 1) * History of hypersensitivity to compounds of similar biological or chemical composition to tafasitamab, immunomodulatory drugs, rituximab, other monocolonal antibodies (mAbs), and/or the excipients contained in the study drug formulations
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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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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Outpatient immunotherapy tested for hard-to-treat lymphomas
- Triple-Drug cocktail aims to boost remission in follicular lymphoma
- New drug combo shows promise for untreated lymphoma patients
- New drug cocktail aims to shrink lymphoma tumors without chemo
- New drug cocktail aims to shrink lymphoma without chemo
- New drug duo aims to control lymphoma without chemo