Actively Recruiting
Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma
Led by M.D. Anderson Cancer Center · Updated on 2026-05-01
30
Participants Needed
1
Research Sites
396 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with relapsed or refractory DLBCL or FL who have failed at least 2 prior therapies, or have had an autologous or allogeneic stem cell transplant
- Prior failure of CAR-T therapy or not eligible for CAR-T cells
- Tumor biopsy positive for CD19 or CD20 at 1% or more by immunohistochemistry or flow cytometry
- Age between 18 and 80 years
- Karnofsky performance status of 60% or higher
- Absolute neutrophil count of 500/mm3 or higher and platelet count of 50,000/mm3 or higher
- Serum creatinine clearance of 30 ml/min or higher estimated by Cockcroft-Gault equation
- Adequate liver function with ALT and/or AST less than or equal to 3 times upper limit of normal (ULN); bilirubin and ALP less than or equal to 2 times ULN (patients with liver cancer involvement and elevations up to 5 times ULN may be eligible per investigator discretion)
- Adequate lung function with FEV1, FVC, and DLCO (corrected) at 50% or higher
- Adequate cardiac function with left ventricular ejection fraction of 40% or higher, no uncontrolled arrhythmias or symptomatic heart disease
- If female of childbearing potential, must have negative pregnancy test prior to enrollment
- Female participants of non-childbearing potential must be postmenopausal, have had hysterectomy or bilateral salpingo-oophorectomy, or have ovarian failure
- Participants of childbearing potential must agree to use effective contraception during treatment and for at least 3 months after
- Male participants must agree to use effective contraception during treatment and for 4 months after
- Agree to sign consent for long-term follow-up
You will not qualify if you...
- Lymphoma in complete remission with no measurable disease
- Major surgery within 4 weeks before first dose of study drug
- Any severe or uncontrolled disease or condition increasing study risk
- Any other active malignancy except treated cervical intra-epithelial neoplasia or non-melanoma skin cancer
- Grade 3 or higher non-hematologic toxicity from prior therapy not improved to grade 2 or less
- Active hepatitis B or C infection
- Active infection requiring intravenous antibiotics
- HIV infection
- Treatment with any anti-cancer agent within 2 weeks prior
- Active untreated central nervous system involvement
- Life expectancy of 6 months or less
- Active uncontrolled neurological disorder
- Receiving systemic steroid therapy at enrollment (except physiological doses) or recent use of certain immunosuppressive therapies
- Receiving immunosuppressive therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
Y
Yago Nieto, MD,PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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