Not Yet RecruitingPhase 1

Rituximab (Rtx) + Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed/Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)

United States15 participantsStarted 2026-09

Plain-language summary

This research study is for people who have relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) that has not responded to two or more lines of therapy. The purpose of this study is to identify the recommended dose of allogeneic NK cells in combination with IL-2, Tafasitamab and Rituximab for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma. NK cells are an investigational (experimental) treatment which means they are not approved by the Food and Drug Administration (FDA). NK cells are a type of lymphocyte that's part of the body's natural immune system, and they can kill cancer cells by creating pores in the cancer cell membranes and inducing apoptosis (programmed cell death). Participants in this study will receive lymphodepleting chemotherapy, as well as Allogeneic NK cells, Tafasitamab and Interleukin-2 (IL-2) by an intravenous (IV) infusion. Participants are expected to complete one cycle, and they may be eligible to complete a second cycle of the same regiment if they have stable disease, partial or complete remission at the end of the first cycle. Participants will be in this study for about 12 months.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 1 trial focused on finding safe doses, so what does that mean for what's actually known right now about whether this combination of rituximab, tafasitamab, and donor NK cells would help my specific type of lymphoma?
2Since the trial isn't recruiting yet, how long might it realistically be before it opens, and should we be looking at other options in the meantime given where my disease stands right now?
3The trial uses allogeneic NK cells, meaning immune cells from a donor rather than my own — what kinds of risks come with receiving someone else's immune cells, and how does that compare to other treatments I might consider?
4Dose-limiting toxicity is the main thing being measured here, which tells me safety is still being established — given that my lymphoma has already relapsed or not responded to prior treatment, is a first-in-human-style safety study the right fit for my situation, or would a different trial or standard salvage therapy make more sense to try first?
5My diagnosis falls under one of several B-cell lymphoma subtypes this trial is targeting — does my specific subtype have any particular reason to respond better or worse to this NK cell and antibody combination, based on what your experience or the early science suggests?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dose limiting toxicity (DLT)

Timeframe: Up to 42 days

Trial details

NCT IDNCT07225439

SponsorPaolo Caimi, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Paolo Caimi, MD

(216) 445-4635 caimip@ccf.org

View on ClinicalTrials.gov More Non Hodgkin Lymphoma trials