Actively Recruiting
Phase I/II 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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of ONC-PluReceptor natural killer (NK) cell therapy combined with the monoclonal antibodies epcoritamab and tafasitamab in adults with relapsed or refractory B-cell Non-Hodgkin lymphoma that expresses CD19 or CD20 markers. The study focuses on establishing the safety and the best dose for this treatment, as well as measuring how well it controls the lymphoma, including response rates and survival times. Participants will receive umbilical cord blood-derived NK cells modified with ONC-PluReceptor, delivered by injection and combined with the two antibody therapies. The trial includes dose escalation and dose expansion phases to find the recommended treatment dose. Treatment cycles will be administered under medical supervision, with monitoring for safety and response. Throughout the study, participants will undergo assessments including tumor biopsies, blood tests, and scans to monitor immune response, side effects, and disease progression. Safety and adverse events will be tracked for about one year, and immune system recovery will be studied. Participants are expected to be followed for long-term effects and treatment outcomes, with the total duration depending on individual responses.
CONDITIONS
Brief 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...
- Adults aged 18 to 80 years
- Diagnosis of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL)
- Failure of two or more prior treatments or previous autologous or allogeneic stem cell transplant
- Prior failure of CAR-T therapy or ineligibility for CAR-T cells
- Tumor biopsy positive for CD19 or CD20 in at least 1% of cells
- Karnofsky performance status of 60% or higher
- Absolute neutrophil count of at least 500/mm3 and platelet count of at least 50,000/mm3
- Serum creatinine clearance of at least 30 ml/min
- Adequate liver function with specific enzyme and bilirubin limits
- Adequate lung function with FEV1, FVC, and DLCO at or above 50%
- Adequate heart function with ejection fraction at or above 40% and no uncontrolled arrhythmias
- Negative pregnancy test for women of child-bearing potential
- Women of childbearing potential must use effective contraception during treatment and for 3 months after
- Men must use effective contraception during treatment and for 4 months after
- Agreement to sign consent for long-term follow-up protocol
You will not qualify if you...
- Lymphoma in complete remission without measurable disease
- Major surgery within 4 weeks before first study drug dose
- Other severe or uncontrolled diseases increasing study risk
- Active other cancers except treated cervical intra-epithelial neoplasia or non-melanoma skin cancer
- Grade 3 or higher non-blood toxicities 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 to enrollment
- Active central nervous system lymphoma involvement
- Life expectancy of 6 months or less
- Active uncontrolled neurological disorders
- Use of systemic steroids at enrollment, except physiological doses
- Recent use of antithymocyte globulin, lymphocyte immune globulin, or alemtuzumab
- Use of immunosuppressive therapy at enrollment
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year
Participants receive ONC-PluReceptor NK cells in combination with epcoritamab and tafasitamab to treat relapsed or refractory B-cell non-Hodgkin lymphoma.
Visits occur regularly during treatment cycles as scheduled by the study team
Duration - Up to study completion (approximately 2 years after treatment start)
Participants are monitored for safety and long-term outcomes after completing treatment.
Periodic visits for safety assessments and response evaluations
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
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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