Recurrent B-Cell Non-Hodgkin LymphomaPhase 1/2NCT07283679
Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma
A Phase 1/2 study testing ONC-PluReceptor NK cells in people with Recurrent B-Cell Non-Hodgkin Lymphoma and Refractory B-cell Non-Hodgkin Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent B-Cell Non-Hodgkin Lymphoma, Refractory B-cell Non-Hodgkin Lymphoma
- What is being tested?
- ONC-PluReceptor NK cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2026to 30 Sep 2033
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Show all 20Show fewer
- 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:
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy. iii. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- o Subjects who are of childbearing potential, sexually active, and at risk of pregnancy must agree to use a highly effective method of contraception for the duration of the active treatment and at least 3 months post-completion of the study therapy. See Appendix B. Highly effective methods of contraception include the following:
- Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- o Men treated or enrolled in this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study agent administration. Men who are able to have children must use effective birth control while in the study. If the male participant fathers a child or suspects that he has fathered a child while in the study, he must immediately notify his doctor.
- Agree to sign the consent to the long-term follow-up protocol PA17-0843 to fulfill the institutional responsibilities to various regulatory agencies
Who cannot join
- 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)
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Yago Nieto, MD,PHD, 713-794-1752, ynieto@mdanderson.org
Yago Nieto, MD,PHD
About this study
Official title: Phase I/II Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma
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.
Read the 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:
- To evaluate the overall response rate (ORR), complete response (CR) rate and partial response (PR) rate of patients treated at the RP2D.
- To evaluate the duration of response (DOR).
- To evaluate the progression-free survival (PFS) rate.
- To evaluate the overall survival (OS) time.
- To quantify the persistence of infused donor NK cells in the recipient.
- To conduct comprehensive immune reconstitution studies.
- Being tested
- ONC-PluReceptor NK cells
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONC-PluReceptor NK cellsDrug
Given by injection
| Study group | Role | What they receive |
|---|---|---|
| Cycle 2: Dose Escalation/ Dose Expansion Treatment with ONC-PluReceptor NK cells | Experimental | Not described Receives: Drug: ONC-PluReceptor NK cells |
| ESC/EXP1_Cycle 1: Dose Escalation/ Dose Expansion Treatment with ONC-PluReceptor NK cells | Experimental | Not described Receives: Drug: ONC-PluReceptor NK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start24 Feb 2026
- Primary completion30 Sep 2031 (estimated)
- Study completion30 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent B-Cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yago Nieto, MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283679
- Sponsor's protocol ID
- 2024-0257
- Other IDs
- NCI-2025-09213
- Status last verified
- Oct 2026
- First submitted
- 11 Dec 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT07283679
- Acronym / sponsor ID
- 2024-0257
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 30 Sep 2031 (estimated)
- Study completion
- 30 Sep 2033 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the overall response rate (ORR), complete response (CR) rate and partial response (PR) rate of patients treated at the RP2D.
- To evaluate the duration of response (DOR).
- To evaluate the progression-free survival (PFS) rate.
- To evaluate the overall survival (OS) time.
- To quantify the persistence of infused donor NK cells in the recipient.
- To conduct comprehensive immune reconstitution studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONC-PluReceptor NK cellsGiven by injection | Drug | 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 |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Recurrent B-Cell Non-Hodgkin Lymphoma
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
Active, not recruitingPhase 1
A Study of Radiation Therapy Before CAR T Cell Therapy for People With B Cell Lymphoma
Non-Hodgkin Lymphoma, Non-Hodgkin's Lymphoma, Relapsed
RecruitingPhase 1/2
A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma
Mature B-Cell Non-Hodgkin Lymphoma
RecruitingPhase 2
Safety and Efficacy of Epcoritamab With Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-cell Lymphoma
Large Cell Lymphoma, Diffuse, Relapsed Cancer
Not yet recruitingPhase 2
Prophylactic Strategies for Mitigating Central Nervous System Relapse in Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma (DLBCL)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yago Nieto, MD,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ONC-PluReceptor NK cells in people with Recurrent B-Cell Non-Hodgkin Lymphoma and Refractory B-cell Non-Hodgkin Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yago Nieto, MD,PHD ((713) 794-1752, ynieto@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.