Health Trials

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

ConditionsNon Hodgkin LymphomaB-cell Non Hodgkin LymphomaDiffuse Large B Cell LymphomaHigh-grade B-cell LymphomaPrimary Mediastinal Large B Cell LymphomaFollicular LymphomaChronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMarginal Zone LymphomaMantle Cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPaolo Caimi, MD

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Allogeneic NK cells
  • Rituximab
  • Tafasitamab
  • Interleukin-2
  • Fludarabine/cyclophosphamide

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators

Paolo Caimi, MD

Lead sponsor

Case Comprehensive Cancer Center

Sponsor institution

Incyte Corporation

Collaborator

Source ClinicalTrials.gov