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

NCT07283679 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2024-0257NCI-2025-09213
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (2)

Cycle 2: Dose Escalation/ Dose Expansion Treatment with ONC-PluReceptor NK cells

EXPERIMENTAL

Drug: ONC-PluReceptor NK cells

ESC/EXP1_Cycle 1: Dose Escalation/ Dose Expansion Treatment with ONC-PluReceptor NK cells

EXPERIMENTAL

Drug: ONC-PluReceptor NK cells

Interventions

ONC-PluReceptor NK cells DRUG

Given by injection

Cycle 2: Dose Escalation/ Dose Expansion Treatment with ONC-PluReceptor NK cells; ESC/EXP1_Cycle 1: Dose Escalation/ Dose Expansion Treatment with ONC-PluReceptor NK cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:
• Estimated creatinine clearance = (140-age \[years\]) x weight (kg) (x Fa) / serum creatinine (mg/dL) x 72 \[a where F=0.85 for females and F=1 for males\].
• 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%.
• Adequate cardiac function with left ventricular ejection fraction \>/=40%, and no uncontrolled arrhythmias or symptomatic cardiac disease.
• If female of child-bearing potential, she must not be pregnant or breastfeeding and required to have a negative urine or serum pregnancy test prior to enrollment.
• Female participants of non-childbearing potential must meet at least one of the following criteria:
• i. Postmenopausal (no menses in greater than or equal to 12 consecutive months).

You may not qualify if:

• 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.
• 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.
• HIV infection.
• Treatment within prior 2 weeks with any anti-cancer agent, investigational or approved.
• Active central nervous system (CNS) involvement (untreated parenchymal brain metastasis or positive cytology of cerebrospinal fluid).
• Life expectancy \</= 6 months.
• Active and uncontrolled neurological disorder.
• Patients receiving systemic steroid therapy at the time of enrollment (physiological substitutive doses are allowed), or have received antithymocyte globulin or lymphocyte immune globulin within 14 days of enrollment or alemtuzumab within 28 days of enrollment.
• Patients receiving immunosuppressive therapy.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yago Nieto, MD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yago Nieto, MD,PHD

CONTACT

(713) 794-1752; ynieto@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 16, 2025
• Study Start: February 24, 2026
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): September 30, 2033
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)