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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Study of Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma

Open Label, Phase 2 Study of CD19 t-haNK and N-803 in Combination With Rituximab in Participants With Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma

Study of Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma (NCT07125872) is a Phase 2 interventional studying Relapsed B-Cell Non Hodgkin Lymphoma, sponsored by ImmunityBio, Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Open Label, Phase 2 Study of CD19 t-haNK and N-803 in Combination with Rituximab in subjects with Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma. 40 Participant will be screened for 20 subjects enrollment.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Relapsed B-Cell Non Hodgkin Lymphoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 1- Age\>18 years old 2- Able to understand and provide a signed willing to sign a consent form that fulfills the relevant Human Research Ethics Committee( HRECC) or independent Ethics Committee( IEC) guidelines 3. Histologically or flow cytometry documented B-cell NHL, (excluding primary central nervous system \[CNS\] lymphoma, chronic lymphocytic leukemia \[CLL\], and Burkitt lymphoma) with the following specific criteria: - Have completed ≥2 lines of cytotoxic chemotherapy. - Have received rituximab or another anti-CD20 antibody. - Have measurable disease by Lugano classification documented within 8 weeks of the time of consent, defined as nodal lesions \>15 mm in the long axis or extranodal lesions \>10 mm in long and short axis, or bone marrow involvement that is biopsy proven. 4\. Eastern Cooperative Oncology Group (ECOG) performance status (Appendix 5) of 0 to 1. 5\. Stated willingness to comply with study procedures. 6. Able to attend required study visits and return for adequate follow-up, as required by this protocol. 7\. Agreement to practice effective contraception for female participants of childbearing potential and nonsterile males. Female participants of childbearing potential must agree to use effective contraception while on study and for at least 30 days after the last dose of study drug. Nonsterile male participants must agree to use a condom while on study and for up to 30 days after the last dose of study drug. Effective contraception includes orals, injectables, surgical sterilization (e.g., vasectomy, tubal ligation), two forms of barrier methods (e.g., condom, diaphragm) and implants such as intrauterine devices (IUDs). Who Should NOT Join This Trial: - Participants with ANY of the following criteria are excluded from participation in the study: 1. Histologically documented primary CNS lymphoma, CLL, Burkitt, Burkitt-like lymphoma. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 1- Age\>18 years old 2- Able to understand and provide a signed informed consent that fulfills the relevant Human Research Ethics Committee( HRECC) or independent Ethics Committee( IEC) guidelines 3. Histologically or flow cytometry documented B-cell NHL, (excluding primary central nervous system \[CNS\] lymphoma, chronic lymphocytic leukemia \[CLL\], and Burkitt lymphoma) with the following specific criteria: * Have completed ≥2 lines of cytotoxic chemotherapy. * Have received rituximab or another anti-CD20 antibody. * Have measurable disease by Lugano classification documented within 8 weeks of the time of consent, defined as nodal lesions \>15 mm in the long axis or extranodal lesions \>10 mm in long and short axis, or bone marrow involvement that is biopsy proven. 4\. Eastern Cooperative Oncology Group (ECOG) performance status (Appendix 5) of 0 to 1. 5\. Stated willingness to comply with study procedures. 6. Able to attend required study visits and return for adequate follow-up, as required by this protocol. 7\. Agreement to practice effective contraception for female participants of childbearing potential and nonsterile males. Female participants of childbearing potential must agree to use effective contraception while on study and for at least 30 days after the last dose of study drug. Nonsterile male participants must agree to use a condom while on study and for up to 30 days after the last dose of study drug. Effective contraception includes orals, injectables, surgical sterilization (e.g., vasectomy, tubal ligation), two forms of barrier methods (e.g., condom, diaphragm) and implants such as intrauterine devices (IUDs). Exclusion Criteria: * Participants with ANY of the following criteria are excluded from participation in the study: 1. Histologically documented primary CNS lymphoma, CLL, Burkitt, Burkitt-like lymphoma. 2. Known hypersensitivity or allergy to any component of the study medications, including sulfa-containing study medication(s) (e.g., albumin \[human\], dimethyl sulfoxide \[DMSO\]). 3. Inadequate organ function, evidenced by the following laboratory results: 1. ANC \< 1000 cells/mm3. 2. Platelet count \< 100,000 cells/mm3. 3. Total bilirubin ≥ 1.5 × the upper limit of normal (ULN; unless the participant has documented Gilbert's syndrome or indirect hyperbilirubinemia). 4. Aspartate aminotransferase (AST \[SGOT\])/ALT (SGPT) ≥ 2.5 × ULN. 5. Alkaline phosphatase (ALP) levels ≥ 2.5 × ULN (or ≥ 5 × ULN in participants with bone metastases). 6. Serum creatinine ≥ 160 µmol/L. NOTE: Each study site should use its institutional ULN to determine eligibility. 4. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the participant at high risk for treatment-related complications. 5. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura requiring steroid therapy defined as \> 20 mg of prednisone or equivalent daily. 6. History of allogeneic hematopoietic stem-cell transplantation (HSCT) requiring ongoing systemic graft versus host disease (GvHD) therapy. 7. Anti-CD20 antibody treatment less than 2 weeks prior to cell infusion. 8. History of receiving allograft organ transplant requiring immunosuppression. 9. Participants post solid organ transplants who develop high grade lymphomas or leukemias. 10. Metastases to the CNS, including parenchyma or leptomeninges. 11. Nonmalignant CNS disease (e.g., stroke, epilepsy, vasculitis, or neurodegenerative disease). 12. History of active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis). 13. Uncontrolled hypertension (systolic \> 160 mm Hg and/or diastolic \> 110 mm Hg) or clinically significant (i.e., active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association (Appendix 6) Class 2 or higher; or serious cardiac arrhythmia requiring medication. 14. Current chronic daily treatment (continuous for \>3 months) with systemiccorticosteroids as defined as \>20 mg of prednisone or equivalent daily, excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed. 15. Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications. 16. Tested positive for tuberculosis (TB) utilizing the QuantiFERON Gold TB test. 17. History of human immunodeficiency virus (HIV) with current CD4+ T-cell count \< 350 cells/μL and a detectable HIV viral load. 18. Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive. 19. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin. 20. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol. 21. Women who are pregnant or breastfeeding.

Treatments Being Tested

BIOLOGICAL

CD19 t-haNK- IV Administration

N-803 Subcutaneous (SQ): N-803 is a novel IL-15 superagonist immunotherapy administered subcutaneously. It is designed to enhance the proliferation and activation of natural killer (NK) cells and CD8+ T cells without stimulating regulatory T cells. N-803 SQ differs from other cytokine therapies due to its improved pharmacokinetic profile, enhanced in vivo activity, and reduced toxicity. CD19-Directed Therapies: CD19-targeted therapies, are biologic agents specifically designed to recognize and eliminate CD19-expressing B-cell malignancies. These therapies differ from traditional chemotherapy or small molecule inhibitors by leveraging the patient's immune system to achieve targeted cytotoxicity. Their mechanism of action involves direct binding to the CD19 antigen on malignant B cells, leading to immune-mediated cell death.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Dr. Jackie Thomson Inc
Johannesburg, South Africa
Albert Cellular Therapy
Pretoria, South Africa

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07125872), the sponsor (ImmunityBio, Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07125872 clinical trial studying?

Open Label, Phase 2 Study of CD19 t-haNK and N-803 in Combination with Rituximab in subjects with Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma. 40 Participant will be screened for 20 subjects enrollment. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07125872?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07125872?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07125872. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07125872. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.