New drug cocktail shows promise for rare blood cancer
NCT ID NCT07261163
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a combination of three drugs (obinutuzumab, zanubrutinib, and lenalidomide) as a first treatment for people with mantle cell lymphoma who have not had any prior therapy. About 37 adults aged 18 to 80 will receive the drugs, and those at higher risk may also get CAR-T cell therapy. The goal is to see how well this approach controls the cancer and whether it can lead to a complete response.
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 37 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jul 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. Age between 18 and 80 years inclusive, both genders are eligible. 2. Histologically or cytologically confirmed diagnosis of Mantle Cell Lymphoma (MCL), with at least one measurable lesion according to Lugano criteria. 3. No prior systemic therapy for MCL. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Adequate organ function, defined as: 1. Hematologic function (without red blood cell or platelet transfusion, growth factor support, or medication correction within 14 days prior to enrollment):Absolute neutrophil count (ANC) ≥ 1 × 10⁹/L;Platelet count (PLT) ≥ 75 × 10⁹/L; 2. Biochemical tests must meet the following criteria:: Total bilirubin ≤ 2.0 × upper limit of normal (ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 × ULN;Creatinine clearance ≥ 30 mL/min, calculated by the Cockcroft-Gault formula; 3. Cardiac function:Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram. 6. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of study treatment, and must agree to use a highly effective method of contraception (e.g., intrauterine device, hormonal contraception, or condom use) during the study and for 6 months after the last dose of study drug. Male subjects whose partners are of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 6 months after the last dose of study drug. 7. Willing and able to provide written informed consent and comply with the study follow-up requirements. Exclusion Criteria: 1. Known central nervous system (CNS) involvement, including brain or meningeal lymphoma. 2. Congestive heart failure with New York Heart Association (NYHA) Class III or IV cardiac dysfunction. 3. History of other primary malignancies within the past 3 years, except for non-melanoma skin cancer, localized prostate cancer considered cured, cervical in situ carcinoma, or squamous intraepithelial lesion detected by PAP smear. 4. Prior treatment with investigational drugs. 5. Active systemic viral, bacterial, or fungal infection requiring antimicrobial therapy within 2 weeks prior to first administration of study drug. 6. Use of immunosuppressive agents within 7 days prior to first administration of study drug, except for intranasal or inhaled corticosteroids, or systemic corticosteroids at physiologic doses (i.e., ≤ 20 mg/day prednisone or equivalent). 7. History of hypersensitivity, allergic reactions, or adverse drug reactions:Severe hypersensitivity reaction to monoclonal antibodies;Allergy or intolerance to infusions;History of severe allergy to study drugs or premedication agents. 8. Physical or laboratory findings:Congenital or acquired immunodeficiency, such as active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (positive HCV antibody and HCV-RNA above lower limit of detection), or co-infection with both HBV and HCV; Pregnant or breastfeeding women; subjects of childbearing potential unwilling or unable to use effective contraception; Known history of positive human immunodeficiency virus (HIV) test or acquired immunodeficiency syndrome (AIDS). 9. Any condition that, in the investigator's judgment, may impair subject safety or ability to comply with the study protocol. 10. Other conditions deemed unsuitable for enrollment 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
2 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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Institute of Hematology & Blood Diseases Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, 300020, China
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Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
RECRUITINGTianjin, Tianjin Municipality, 300020, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Triple drug combo targets mantle cell lymphoma
- New drug joins standard chemotherapy in fight against B-Cell lymphoma
- Which lymphoma drug combo works best? a new study aims to find out
- Can a Three-Drug combo erase mantle cell lymphoma without chemotherapy?
- Can a single injection reprogram immune cells to fight cancer?