Study of Rituximab + Tafasitamab with NK Cells for Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
This study is for people with B-cell non-Hodgkin lymphoma (NHL) that has come back or not responded to at least two previous treatments. It is testing a combination of several drugs: Rituximab, Tafasitamab, Interleukin-2, Fludarabine/cyclophosphamide, and allogeneic NK cells. NK cells are a type of immune cell that can kill cancer cells and are considered an experimental treatment. The main goal is to find the safest and most effective dose of the allogeneic NK cells when given with the other medications. Researchers will be looking for any serious side effects within the first 42 days. This study plans to enroll 15 participants who are 18 years or older and have certain types of B-cell NHL.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 15 participants to test different doses of the NK cells.
- What's involved
- Participants will receive Fludarabine/cyclophosphamide for 3 days, followed by Rituximab, Tafasitamab, Interleukin-2, and allogeneic NK cells weekly for 3 weeks. Rituximab may be given again in a second cycle if applicable.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint for safety is measured up to 42 days after treatment.
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NCT07225439
Rituximab (Rtx) + Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed/Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)
Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatmentPaolo Caimi, MDInvestigator-initiated
~15 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:Allogeneic NK cellsRituximabTafasitamabInterleukin-2Fludarabine/cyclophosphamide
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicity (DLT)
Measured over Up to 42 days
Conditions
Where it's being run
2 sites across 1 statesOhio2
Study leadership
- Paolo Caimi, MD · PRINCIPAL_INVESTIGATOR · Case Comprehensive Cancer Center, Cleveland Clinic
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Age 18 years or older
Diagnosis of B-cell NHL (indolent and aggressive subtypes) including diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), high grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)
Participants must have measurable disease as defined by Lugano 2014 criteria for NHL or iwCLL 2018 criteria for CLL. For NHL, measurable disease is defined as ≥1 measurable lesion (nodal or extra nodal) ≥1.5 cm in longest diameter by CT or PET/CT. For CLL, iwCLL criteria includes: presence of lymphocytosis (e.g., ALC ≥5 × 10⁹/L), lymphadenopathy ≥1.5 cm, and/or disease-related cytopenias (anemia, thrombocytopenia).
Relapsed and/or refractory after two or more lines of systemic therapy, including prior CD19 and/or CD20 directed therapies
For participants who have received a prior CD19 or CD20 directed therapy, the presence of CD19 and/or CD20 expression (by flow cytometry and/or immunohistochemistry) must be demonstrated on a post-treatment relapse biopsy
ECOG Performance Status \</= 2
Preserved organ function as defined by: Total bilirubin \</= 1.5X upper limit of normal; AST/ALT \</= 2.5 X upper limit of normal; Calculated creatinine clearance \>/= 30mL/min estimated by Cockcroft Gualt formula; cardiac ejection fraction \>/= 45% and no more than mild/trace pericardial effusion on a recent echocardiogram; and adequate pulmonary function with oxygen saturation \>/= 92% on room air.
Participants must have the ability to understand and the willingness to sign a written informed consent document
Exclusion
Second active malignancy (other than non-melanoma skin cancer or carcinoma in situ e.g. cervix, bladder, breast) that would confound interpretation of toxicity assessment or limit survival to prevent evaluation of therapy per discretion of principal investigator. Malignancies treated curatively or with hormonal therapy could be included after discussion with the principal investigator
Less than 28 days elapsed between prior treatment with investigational agent(s) and study enrollment
New York Heart Association class III-IV congestive heart failure
Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration
Known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness, except well controlled HIV with viral load \<200 copies/mL on antiretroviral therapy
Pregnant or breastfeeding women are excluded from this study because therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants' secondary to treatment of the mother with NK cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study
Morphologic and/or cytogenetic features consistent with diagnosis of myelodysplastic syndrome on the most recent bone marrow biopsy prior to initiation of therapy
Serologic status reflecting active hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive participants will be excluded)
Participants with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease
Active central nervous system or leptomeningeal involvement by lymphoma. Participants with untreated brain metastases/CNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurological and other adverse events. Participants with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast enhanced MRI imaging for at least 90 days prior to registration
History of active autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of systemic immunosuppressive medications other than low dose steroids \[i.e. maximum of 15mg prednisone equivalent\] within the last 6 months
What this trial measures
- Dose limiting toxicity (DLT)Up to 42 days
Non hematologic AEs will be measured during cycle 1 (first 28 days) and hematologic AEs will be measured during the first 42 days for all dose levels. DLTs are graded for severity by the Common Terminology Criteria for Adverse Events v5.0 (CTCAEv5.0) criteria.