Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or… (NCT07283679) | Clinical Trial Compass
RecruitingPhase 1/2
Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma
United States30 participantsStarted 2026-02-24
Plain-language summary
The goal of this clinical research study is to learn if ONC-PluReceptor NK cell therapy (combined with the monoclonal antibody therapies epcoritamab and tafasitamab) can help to control relapsed or refractory B-cell Non-Hodgkin Lymphoma. The safety of this treatment will also be studied.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with R/R DLBCL or FL with all of the following:
✓. Tumor biopsy positive for CD19 or CD20 at \>/= 1% by immunohistochemistry or flow cytometry.
✓. Age 18-80 years.
✓. Karnofsky performance status \>/=60%.
✓. Absolute neutrophil count \>/=500/mm3 and platelet count \>/=50,000/mm3.
✓. Serum creatinine clearance (CrCl) \>/=30 ml/min, estimated using the Cockcroft-Gault equation:
✓. Adequate hepatic function (ALT and/or AST \</=3 x upper limit of normal (ULN); bilirubin and ALP \</=2 x ULN). Patients with cancer involvement of the liver and elevation of ALT, AST, bilirubin, and/or ALP \</= 5 x ULN are eligible, per PI discretion.
✓. Adequate pulmonary function with FEV1, FVC and DLCO (corrected for hemoglobin and volume) \>/=50%.
Exclusion criteria
✕. Lymphoma in CR with no measurable sites of disease.
✕. Major surgery \<4 weeks prior to first dose of study drug.
✕. Any other severe or uncontrolled disease or condition that might increase the risk associated with study participation.
✕. Any other malignancy known to be active, with the exception of treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year.
✕. Grade \>/= 3 non-hematologic toxicity from prior therapy that has not improved to grade \</= 2.
✕. Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA.\>/=10,000 copies/mL, or \>/=2,000 IU/mL), or hepatitis C (detectable viral load by HCV RNA PCR)
✕. Active infection requiring parenteral antibiotics.