Phase I/II Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma
M.D. Anderson Cancer Center
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.
Description
Primary Objective: To establish the safety and recommended phase II dose (RP2D) of umbilical cord blood (CB)- derived natural killer (NK) cells transduced with ONC-PluReceptor (CD3 complex/IL-15) in combination with epcoritamab and tafasitamab for patients with relapsed/refractory (R/R) CD19/CD20-positive B-cell non-Hodgkin lymphomas. Secondary Objectives: 1. To evaluate the overall response rate (ORR), complete response (CR) rate and partial response (PR) rate of patients treated at the RP2D. 2. To evaluate the duration of response (DOR). 3. To evaluate the progression-free survival (PFS)…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with R/R DLBCL or FL with all of the following: Failure of \>/= 2 prior lines of therapy, or an autologous or allogeneic stem cell transplant. Prior failure of CAR-T or not eligible for CAR-T cells. 2. Tumor biopsy positive for CD19 or CD20 at \>/= 1% by immunohistochemistry or flow cytometry. 3. Age 18-80 years. 4. Karnofsky performance status \>/=60%. 5. Absolute neutrophil count \>/=500/mm3 and platelet count \>/=50,000/mm3. 6. Serum creatinine clearance (CrCl) \>/=30 ml/min, estimated using the Cockcroft-Gault equation: Estimated creatinine clea…
Interventions
- DrugONC-PluReceptor NK cells
Given by injection
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas