NCT07283679

Phase I/II Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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) rate. 4. To evaluate the overall survival (OS) time. 5. To quantify the persistence of infused donor NK cells in the recipient. 6. To conduct comprehensive immune reconstitution studies.

Conditions

• Recurrent B-Cell Non-Hodgkin Lymphoma
• Refractory B-cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	ONC-PluReceptor NK cells	Given by injection

Timeline

• Start date: 2026-06-01
• Primary completion: 2031-09-30
• Completion: 2033-09-30
• First posted: 2025-12-16
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study